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

JRCT ID: jRCT2071240029

Registered date:05/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy Adult Male Volunteers
• Date of first enrollment: 04/07/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Single intravenous infusion of the investigational drug

Outcome(s)

Primary Outcome

- Number of treatment-emergent adverse events, including type, intensity, and causality.
- Change from baseline in vital signs, 12-lead electrocardiogram (ECG), haematology, clinical chemistry, haemostasis, and urinalysis parameters after a single IV dose infusion.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

- Japanese men with 18 to 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 delegated person) at screening and on Day -1

• Exclude 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).

Related Information

• Primary Sponsor: Imura Futoshi