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A Clinical Study of AK139 in Healthy Subjects
Sponsor: Akeso
Summary
This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.
Official title: A Phase I Clinical Study on Dose Escalation Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of AK139 in Healthy Subjects.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-05-06
Completion Date
2026-01-30
Last Updated
2025-04-27
Healthy Volunteers
Yes
Conditions
Interventions
Placebo
Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.
AK111
The study will use dose escalation scheme. Before proceeding to randomize the next group of subjects, the safety data from all subjects in the previous dose group must be reviewed and confirmed.
Locations (1)
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China