drugset / Trial / NCT06173011
A Study Comparing Pharmacokinetic and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Adults
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2107 with Keytruda® marketed in China and the United States in healthy male volunteers. Participants will receive a single injection of QL2107/ Keytruda® (China)/Keytruda® (US).Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the three groups.
Timeline
- Start
- 2023-12-12
- Primary completion
- 2024-07
- Completion
- 2024-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pembrolizumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | QL2107 | Unknown | 100 mg | Intravenous |