NCT05383378

Brief Summary

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2 sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

May 4, 2022

Last Update Submit

November 10, 2023

Conditions

Atopic Dermatitis

Keywords

Atopic EczemaNeurodermatitis

Outcome Measures

Primary Outcomes (122)

  • Adverse events (AEs)

    AEs will be summarized and tabulated according to the primary system organ class and preferred term. Separate analyses will be conducted using severity, seriousness, and relationship to the IMP.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Adverse events (AEs)

    AEs will be summarized and tabulated according to the primary system organ class and preferred term. Separate analyses will be conducted using severity, seriousness, and relationship to the IMP.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter plateletes to all assessments during the study

    For the analyses of hematology parameter platelets the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter plateletes to all assessments during the study

    For the analyses of hematology parameter platelets the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter erythrocytes to all assessments during the study

    For the analyses of hematology parameter erythrocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter erythrocytes to all assessments during the study

    For the analyses of hematology parameter erythrocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter leukocytes to all assessments during the study

    For the analyses of hematology parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter leukocytes to all assessments during the study

    For the analyses of hematology parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter differential leukocyte count to all assessments during the study

    For the analyses of hematology parameter differential leukocyte count the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter differential leukocyte count to all assessments during the study

    For the analyses of hematology parameter differential leukocyte count the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter hemoglobin to all assessments during the study

    For the analyses of hematology parameter hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter hemoglobin to all assessments during the study

    For the analyses of hematology parameter hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter hematocrit to all assessments during the study

    For the analyses of hematology parameter hematocrit the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter hematocrit to all assessments during the study

    For the analyses of hematology parameter hematocrit the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter mean corpuscular volume to all assessments during the study

    For the analyses of hematology parameter mean corpuscular volume the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter mean corpuscular volume to all assessments during the study

    For the analyses of hematology parameter mean corpuscular volume the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter mean corpuscular hemoglobin to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter mean corpuscular hemoglobin to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in hematology parameter mean corpuscular hemoglobin concentration to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin concentration the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in hematology parameter mean corpuscular hemoglobin concentration to all assessments during the study

    For the analyses of hematology parameter mean corpuscular hemoglobin concentration the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in alanine aminotransferase to all assessments during the study

    For the analyses of alanine aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in alanine aminotransferase to all assessments during the study

    For the analyses of alanine aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in aspartate aminotransferase to all assessments during the study

    For the analyses of aspartate aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in aspartate aminotransferase to all assessments during the study

    For the analyses of aspartate aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in gamma-glutamyl transferase to all assessments during the study

    For the analyses of gamma-glutamyl transferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in gamma-glutamyl transferase to all assessments during the study

    For the analyses of gamma-glutamyl transferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in alkaline phosphatase to all assessments during the study

    For the analyses of alkaline phosphatase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in alkaline phosphatase to all assessments during the study

    For the analyses of alkaline phosphatase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in total bilirubin to all assessments during the study

    For the analyses of total bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in total bilirubin to all assessments during the study

    For the analyses of total bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in unconjugated (indirect) bilirubin to all assessments during the study

    For the analyses of unconjugated (indirect) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in unconjugated (indirect) bilirubin to all assessments during the study

    For the analyses of unconjugated (indirect) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in conjugated (direct) bilirubin to all assessments during the study

    For the analyses of conjugated (direct) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in conjugated (direct) bilirubin to all assessments during the study

    For the analyses of conjugated (direct) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood urea nitrogen to all assessments during the study

    For the analyses of blood urea nitrogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood urea nitrogen to all assessments during the study

    For the analyses of blood urea nitrogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in creatinine to all assessments during the study

    For the analyses of creatinine the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in creatinine to all assessments during the study

    For the analyses of creatinine the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in uric acid to all assessments during the study

    For the analyses of uric acid the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in uric acid to all assessments during the study

    For the analyses of uric acid the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in estimated glomerular filtration rate to all assessments during the study

    For the analyses of estimated glomerular filtration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in estimated glomerular filtration rate to all assessments during the study

    For the analyses of estimated glomerular filtration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter sodium to all assessments during the study

    For the analyses of blood biochemistry parameter sodium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter sodium to all assessments during the study

    For the analyses of blood biochemistry parameter sodium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter potassium to all assessments during the study

    For the analyses of blood biochemistry parameter potassium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter potassium to all assessments during the study

    For the analyses of blood biochemistry parameter potassium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter magnesium to all assessments during the study

    For the analyses of blood biochemistry parameter magnesium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter magnesium to all assessments during the study

    For the analyses of blood biochemistry parameter magnesium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter chloride to all assessments during the study

    For the analyses of blood biochemistry parameter chloride the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter chloride to all assessments during the study

    For the analyses of blood biochemistry parameter chloride the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter inorganic phosphate to all assessments during the study

    For the analyses of blood biochemistry parameter inorganic phosphate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter inorganic phosphate to all assessments during the study

    For the analyses of blood biochemistry parameter inorganic phosphate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter calcium to all assessments during the study

    For the analyses of blood biochemistry parameter calcium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter calcium to all assessments during the study

    For the analyses of blood biochemistry parameter calcium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter creatine phosphokinase to all assessments during the study

    For the analyses of blood biochemistry parameter creatine phosphokinase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter creatine phosphokinase to all assessments during the study

    For the analyses of blood biochemistry parameter creatine phosphokinase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter amylase to all assessments during the study

    For the analyses of blood biochemistry parameter amylase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter amylase to all assessments during the study

    For the analyses of blood biochemistry parameter amylase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter lipase to all assessments during the study

    For the analyses of blood biochemistry parameter lipase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter lipase to all assessments during the study

    For the analyses of blood biochemistry parameter lipase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter total protein to all assessments during the study

    For the analyses of blood biochemistry parameter total protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter total protein to all assessments during the study

    For the analyses of blood biochemistry parameter total protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter albumin to all assessments during the study

    For the analyses of blood biochemistry parameter albumin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter albumin to all assessments during the study

    For the analyses of blood biochemistry parameter albumin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry parameter glucose (non-fasting) to all assessments during the study

    For the analyses of blood biochemistry parameter glucose (non-fasting) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry parameter glucose (non-fasting) to all assessments during the study

    For the analyses of blood biochemistry parameter glucose (non-fasting) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry hemoglobin A1c to all assessments during the study

    For the analyses of blood biochemistry parameter hemoglobin A1c the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry hemoglobin A1c to all assessments during the study

    For the analyses of blood biochemistry parameter hemoglobin A1c the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry triglycerides to all assessments during the study

    For the analyses of blood biochemistry parameter triglycerides the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry triglycerides to all assessments during the study

    For the analyses of blood biochemistry parameter triglycerides the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry cholesterol to all assessments during the study

    For the analyses of blood biochemistry parameter cholesterol the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry cholesterol to all assessments during the study

    For the analyses of blood biochemistry parameter cholesterol the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry ferritin to all assessments during the study

    For the analyses of blood biochemistry parameter ferritin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry ferritin to all assessments during the study

    For the analyses of blood biochemistry parameter ferritin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry D-dimer to all assessments during the study

    For the analyses of blood biochemistry parameter D-dimer the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry D-dimer to all assessments during the study

    For the analyses of blood biochemistry parameter D-dimer the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry lactate dehydrogenase to all assessments during the study

    For the analyses of blood biochemistry parameter lactate dehydrogenase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry lactate dehydrogenase to all assessments during the study

    For the analyses of blood biochemistry parameter lactate dehydrogenase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood biochemistry C-reative protein to all assessments during the study

    For the analyses of blood biochemistry parameter C-reactive protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood biochemistry C-reative protein to all assessments during the study

    For the analyses of blood biochemistry parameter C-reactive protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood coagulation partial thromboplastin time to all assessments during the study

    For the analyses of blood coagulation parameter partial thromboplastin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood coagulation partial thromboplastin time to all assessments during the study

    For the analyses of blood coagulation parameter partial thromboplastin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood coagulation parameter prothrombin time to all assessments during the study

    For the analyses of blood coagulation parameter prothrombin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood coagulation parameter prothrombin time to all assessments during the study

    For the analyses of blood coagulation parameter prothrombin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood coagulation parameter international normalized ratio (INR) all assessments during the study

    For the analyses of blood coagulation parameter international normalized ratio (INR) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood coagulation parameter international normalized ratio (INR) all assessments during the study

    For the analyses of blood coagulation parameter international normalized ratio (INR) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter pH to all assessments during the study

    For the analyses of urinalysis parameter pH the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter pH to all assessments during the study

    For the analyses of urinalysis parameter pH the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter leukocytes to all assessments during the study

    For the analyses of urinalysis parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter leukocytes to all assessments during the study

    For the analyses of urinalysis parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter nitrites to all assessments during the study

    For the analyses of urinalysis parameter nitrites the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter nitrites to all assessments during the study

    For the analyses of urinalysis parameter nitrites the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter blood to all assessments during the study

    For the analyses of urinalysis parameter blood the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter blood to all assessments during the study

    For the analyses of urinalysis parameter blood the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter protein to all assessments during the study

    For the analyses of urinalysis parameter protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter protein to all assessments during the study

    For the analyses of urinalysis parameter protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter glucose to all assessments during the study

    For the analyses of urinalysis parameter glucose the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter glucose to all assessments during the study

    For the analyses of urinalysis parameter glucose the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter ketones to all assessments during the study

    For the analyses of urinalysis parameter ketones the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter ketones to all assessments during the study

    For the analyses of urinalysis parameter ketones the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter urobilinogen to all assessments during the study

    For the analyses of urinalysis parameter urobilinogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter urobilinogen to all assessments during the study

    For the analyses of urinalysis parameter urobilinogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in urinalysis parameter bilirubin to all assessments during the study

    For the analyses of urinalysis parameter bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in urinalysis parameter bilirubin to all assessments during the study

    For the analyses of urinalysis parameter bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in 12-lead ECG parameter PR-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter PR-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in 12-lead ECG parameter PR-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter PR-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in 12-lead ECG parameter QRS-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QRS-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in 12-lead ECG parameter QRS-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QRS-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in 12-lead ECG parameter QT-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QT-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in 12-lead ECG parameter QT-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QT-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in 12-lead ECG parameter QTc[F]-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QTc\[F\]-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in 12-lead ECG parameter QTc[F]-interval to all assessments during the study

    For the analyses of 12-lead ECG parameter QTc\[F\]-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in peripheral oxygen saturation to all assessments during the study

    For the analyses of peripheral oxygen saturation the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in peripheral oxygen saturation to all assessments during the study

    For the analyses of peripheral oxygen saturation the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in blood pressure to all assessments during the study

    For the analyses of blood pressure the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in blood pressure to all assessments during the study

    For the analyses of blood pressure the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in heart rate to all assessments during the study

    For the analyses of heart rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in heart rate to all assessments during the study

    For the analyses of heart rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in respiration rate to all assessments during the study

    For the analyses of respiration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in respiration rate to all assessments during the study

    For the analyses of respiration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

  • Change from Baseline in body temperature to all assessments during the study

    For the analyses of body temperature the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    SAD part: Between Day 1 (IMP injection) and Day 8 (last visit)

  • Change from Baseline in body temperature to all assessments during the study

    For the analyses of body temperature the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

    MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)

Secondary Outcomes (9)

  • SAD part: Plasma concentration of free si-544 in blood plasma at Day 1

    Day 1

  • MAD part: Plasma concentration of free si-544 in blood plasma at Days 1 and 25

    Day 1 and Day 25

  • MAD part: Change from Baseline in number of T cells in peripheral blood at Day 29, and Weeks 8, 12, and 16

    Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)

  • MAD part: Change from Baseline in immunophenotyping of T-cell subsets at Day 29, and Weeks 8, 12, and 16

    Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)

  • MAD part: Change from Baseline in serum cytokine levels at Day 29, and Weeks 8, 12, and 16

    Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)

  • +4 more secondary outcomes

Study Arms (2)

si-544

EXPERIMENTAL

The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo.

Drug: si-544

Placebo

PLACEBO COMPARATOR

The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo.

Drug: Placebo

Interventions

si-544DRUG

Subcutaneous injection in the abdomen

si-544
PlaceboDRUG

Subcutaneous injection in the abdomen

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • SAD and MAD part
  • Change (ie, starting anew, change in frequency, or change in drug substance) in standard systemic and topical therapy, or in immunosuppressive drug therapy within 4 weeks before Screening (for biologics such as dupilumab, the therapy may not be changed within 12 weeks before Screening), as judged by the investigator
  • Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP
  • Uncontrolled hypertension or uncontrolled diabetes
  • History of seizures
  • Presence or history of paresthesia or neuropathy
  • Clinically significant ECG abnormalities, as judged by the investigator
  • Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease, as judged by the investigator
  • Presence of acute infection within 7 days before Screening, as judged by the investigator
  • Known or active infection with Mycobacterium tuberculosis
  • Known or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
  • Vaccination within 2 weeks before Screening and/or planned vaccination during the SAD part or the treatment period of the MAD part
  • Pregnancy
  • Current or previous (within 4 weeks before Screening) participation in another clinical study with an investigational medicinal product or medical device
  • Known or suspected abuse of alcohol, drugs, or medicinal products
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

selectION Clinical Trial Site

Berlin, Germany

Location

selectION Clinical Trial Site

Hamburg, Germany

Location

selectION Clinical Trial Site

Magdeburg, Germany

Location

selectION Clinical Trial Site

Mainz, Germany

Location

selectION Clinical Trial Site

Wuppertal, Germany

Location

MeSH Terms

Conditions

Dermatitis, AtopicNeurodermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Andreas Klostermann, Dr.

    selectION Therapeutics GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The study consists of 2 parts, a single ascending dose (SAD) part, and a multiple ascending dose (MAD) part.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 20, 2022

Study Start

August 30, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in sanctioning by EU data protection authorities. The sponsor wants to avoid this.

Locations

DE(5)