A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons

NCT06298032 | Completed Phase 1

• 1 other identifier: 000414
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases.

Conditions

Inflammatory Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (13)

• Number of treatment-emergent adverse events, including type, intensity, and causality

  End of trial (up to 64 days)

• Change in vital signs from baseline to Day 36 after a single dose infusion

  Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 36 after a single dose infusion (part A of the study).

  From baseline up to and including Day 36 after a single dose infusion

• Change in vital signs from baseline to Day 64 after multiple dose infusions

  Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  From baseline up to and including Day 64 after multiple dose infusions

• Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion

  Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  From baseline up to and including Day 36 after a single dose infusion

• Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions

  Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  From baseline up to and including Day 64 after multiple dose infusions

• Change in haematology from baseline to Day 36 after a single dose infusion

  Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes), from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  From baseline to Day 36 after a single dose infusion

• Change in haematology from baseline to Day 64 after multiple dose infusions

  Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  From baseline to Day 64 after multiple dose infusions

• Change in clinical chemistry from baseline to Day 36 after a single dose infusion

  Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  From baseline to Day 36 after a single dose infusion

• Change in clinical chemistry from baseline to Day 64 after multiple dose infusions

  Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  From baseline up to and including Day 64 after multiple dose infusions

• Change in haemostasis parameters from baseline to Day 36 after a single dose infusion

  Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  From baseline up to and including Day 36 after a single dose infusion

• Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions

  Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  From baseline up to and including Day 64 after multiple dose infusions

• Change in urinalysis parameters from baseline to Day 36 after a single dose infusion

  Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  From baseline to Day 36 after a single dose infusion

• Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions

  Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  From baseline up to and including Day 64 after multiple dose infusions

Secondary Outcomes (20)

• Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf)

  From baseline up to and including Day 36 after a single dose infusion

• Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)

  From baseline up to and including Day 36 after a single dose infusion

• Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi)

  From baseline up to and including Day 36 after a single dose infusion

• Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)

  From baseline up to and including Day 36 after a single dose infusion

• Single-dose PK of FE 999301: Time of maximum observed concentration (tmax)

  From baseline up to and including Day 36 after a single dose infusion

Study Arms (4)

Olamkicept - Part A

EXPERIMENTAL

Drug: Olamkicept Part A

Placebo - Part A

PLACEBO COMPARATOR

Drug: Placebo

Olamkicept - Part B

EXPERIMENTAL

Drug: Olamkicept Part B

Placebo - Part B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Olamkicept Part A DRUG

Intravenous infusion. Single dose. Part A consists of 3 different doses * 1200 mg * 1800 mg * 2400 mg

Also known as: FE 999301

Olamkicept - Part A

Olamkicept Part B DRUG

Intravenous infusion. Multiple doses. Part B consists of 3 different doses. * 1200 mg * 1800 mg * 2400 mg

Also known as: FE 999301

Olamkicept - Part B

Placebo DRUG

Intravenous infusion

Placebo - Part A; Placebo - Part B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men ≥18 and ≤45 years of age at screening
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or designee) at screening and on Day -1

You may not qualify if:

• History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, psychiatric, immunological, haematological, oncological, endocrine, and metabolic systems and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Ferring Investigational Site

Berlin, Germany

Location

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 7, 2024
• Study Start: February 20, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)