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

NCT ID: NCT06515834

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroenterology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

FE 999301

Group Type ACTIVE_COMPARATOR

FE 999301

Intervention Type DRUG

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

Interventions

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FE 999301

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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,
* 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

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Ferring Investigational Site

Sumida-Ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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000435

Identifier Type: -

Identifier Source: org_study_id