NCT06298032

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

A Placebo-controlled, Within-group Randomised, and Double-blind Trial Investigating Safety, Tolerability, and Pharmacokinetics of FE 999301 After Ascending Single and Multiple Doses in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Olamkicept Part A	Intravenous infusion. Single dose. Part A consists of 3 different doses * 1200 mg * 1800 mg * 2400 mg
DRUG	Olamkicept Part B	Intravenous infusion. Multiple doses. Part B consists of 3 different doses. * 1200 mg * 1800 mg * 2400 mg
DRUG	Placebo	Intravenous infusion

Timeline

• Start date: 2024-02-20
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2024-03-07
• Last updated: 2024-11-19

Locations

1 site across 1 country: Germany