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

Ferring

Status and phase: Completed; Phase 1

Conditions: Gastroenterology

Treatments: Drug: Placebo; Drug: FE 999301

Study type: Interventional

Funder types: Industry

Identifiers

NCT06515834

000435

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

FE 999301

Active Comparator group

Treatment:

Drug: FE 999301