drugset / Trial / NCT07400744
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male subjects.
Timeline
- Start
- 2026-03
- Primary completion
- 2026-09
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Daratumumab | Monoclonal antibody | — | Intravenous |
| Subject | QL2109 | Monoclonal antibody | — | Intravenous |