drugset / Trial / NCT05337267
Phase I Study of Sintilimab in Healthy Chinese Male Subjects
RandomizedParallel-groupQuadruple-blindOther
Summary
The purpose of this study is to evaluate the pharmacokinetic similarity of sintilimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process，also to determine Pharmacodynamics of sintilimab with different manufacturing process in 12 healthy male subjects.
Timeline
- Start
- 2022-04-13
- Primary completion
- 2023-05-24
- Completion
- 2023-07-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sintilimab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
Indications
No indication recorded.