drugset / Trial / NCT07340476
A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects
RandomizedParallel-groupQuadruple-blindOther
Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) similarity of AK112 (an anti-PD-1/VEGF bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male subjects. Secondary objectives are to assess the safety, tolerability, and immunogenicity of AK112 from the proposed new manufacturing site and the approved original site.
Timeline
- Start
- 2025-12-11
- Primary completion
- 2026-04-10
- Completion
- 2026-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivonescimab | Monoclonal antibody | 3 mg/kg | Intravenous |
Indications
No indication recorded.