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

NCT06515834 | Completed Phase 1

• 1 other identifier: 000435
• Study Type: interventional
• Target: 24
• 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, 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, to support the clinical development program. The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases.

Conditions

Gastroenterology

Outcome Measures

Primary Outcomes (24)

• Number treatment-emergent adverse events

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

  From baseline up to 36 days after a single dose infusion

• Blood pressure

  Change from baseline in vital signs comprising systolic and diastolic blood pressure

  From baseline up to 36 days after a single dose infusion

• Pulse

  Change from baseline in vital signs comprising pulse

  From baseline up to 36 days after a single dose infusion

• Body temperature

  Change from baseline in vital signs comprising body temperature

  From baseline up to 36 days after a single dose infusion

• Heart rate

  Change from baseline in 12-lead electrocardiogram (ECG) assessing heart rate after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• PR interval

  Change from baseline in 12-lead electrocardiogram ECG assessing the PR interval after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• RR interval

  Change from baseline in 12-lead ECG assessing the RR interval after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• QRS duration

  Change from baseline in 12-lead ECG assessing QRS duration after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• QT interval

  Change from baseline in 12-lead ECG assessing QT interval after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• QTc interval

  Change from baseline in 12-lead electrocardiogram (ECG) assessing QTc interval after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• QRS axis

  Change from baseline in 12-lead ECG assessing QRS axis after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• Change in haematology

  Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (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.

  From baseline up to 36 days after a single dose infusion

• Clinical chemistry

  Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotranferase (ALT), albumin, alkaline phosphatase, aspartate aminotranferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltranferase, 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.

  From baseline up to 36 days after a single dose infusion

• Haemostasis

  Blood and urine samples to assess change from baseline in haemostasis after a single IV dose infusion.

  From baseline up to 36 days after a single dose infusion

• Protein urinalysis parameter

  Number of participants with clinically significant abnormal findings in protein urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Glucose urinalysis parameter

  Number of participants with clinically significant abnormal findings in glucose urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Bilirubin urinalysis parameter

  Number of participants with clinically significant abnormal findings in bilirubin urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• pH urinalysis parameter

  Number of participants with clinically significant abnormal findings in pH urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Nitrate urinalysis parameter

  Number of participants with clinically significant abnormal findings in nitrate urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Ketone urinalysis parameter

  Number of participants with clinically significant abnormal findings in ketone urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Urobilinogen urinalysis parameter

  Number of participants with clinically significant abnormal findings in urobilinogen urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Blood urinalysis parameter

  Number of participants with clinically significant abnormal findings in blood urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Leukocyte urinalysis parameter

  Number of participants with clinically significant abnormal findings in leukocyte urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

• Specific gravity urinalysis parameter

  Number of participants with clinically significant abnormal findings in specific gravity urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.

  From baseline up to 36 days after a single dose infusion

Secondary Outcomes (9)

• Area under the Curve to Infinity (AUCinf)

  From baseline up to 36 days after a single dose infusion

• Area Under the Curve last concentration (AUClast)

  From baseline up to 36 days after a single dose infusion

• Concentration at the end of infusion (Ceoi)

  From baseline up to 36 days after a single dose infusion

• Maximum concentration (Cmax)

  From baseline up to 36 days after a single dose infusion

• Time to reach maximum concentration (tmax)

  From baseline up to 36 days after a single dose infusion

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

FE 999301

ACTIVE COMPARATOR

Drug: FE 999301

Interventions

FE 999301 DRUG

To assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men

FE 999301

Placebo DRUG

Placebo to assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men

Placebo

Eligibility Criteria

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

You may qualify if:

• In good health, determined by:
• no clinically significant findings from medical history,
• physical examination,
• lead electrocardiogram (ECG),
• vital signs measurements,
• and clinical laboratory evaluations

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,
• immunological,
• haematological,
• endocrine,
• and metabolic systems,
• as well as oncological,
• psychiatric,
• dermatological,

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Ferring Investigational Site

Sumida-Ku, Tokyo, 130-0004, Japan

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: July 1, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2024
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)