Status:
COMPLETED
Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese Persons
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Gastroenterology
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 bow...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06515834
Start Date
July 1 2024
End Date
November 28 2024
Last Update
December 6 2024
Active Locations (1)
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1
Ferring Investigational Site
Sumida-Ku, Tokyo, Japan, 130-0004