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

NCT ID: NCT06298032

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-11-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Olamkicept - Part A

Group Type: EXPERIMENTAL

Olamkicept Part A

Intervention Type: DRUG

Intravenous infusion. Single dose.

Part A consists of 3 different doses

• 1200 mg
• 1800 mg
• 2400 mg

Placebo - Part A

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous infusion

Olamkicept - Part B

Group Type: EXPERIMENTAL

Olamkicept Part B

Intervention Type: DRUG

Intravenous infusion. Multiple doses.

Part B consists of 3 different doses.

• 1200 mg
• 1800 mg
• 2400 mg

Placebo - Part B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous infusion

Interventions

Olamkicept Part A

Intravenous infusion. Single dose.

Part A consists of 3 different doses

• 1200 mg
• 1800 mg
• 2400 mg

Intervention Type: DRUG

Olamkicept Part B

Intravenous infusion. Multiple doses.

Part B consists of 3 different doses.

• 1200 mg
• 1800 mg
• 2400 mg

Intervention Type: DRUG

Placebo

Intravenous infusion

Intervention Type: DRUG

Other Intervention Names

FE 999301; FE 999301

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Ferring Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

000414

Identifier Type: -

Identifier Source: org_study_id