A Clinical Study of AK139 in Healthy Subjects
NCT06947109 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-04-27
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.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.
- DRUG
-
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.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-06
- Primary Completion
- 2026-01-30
- Completion
- 2026-01-30
Countries
- China
Study Locations
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