drugset / Trial / NCT06371534
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2109 with DARZALEX FASPRO® in healthy male volunteers. Participants will receive a single injection of QL2109/ DARZALEX FASPRO® Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the two groups.
Timeline
- Start
- 2024-04-12
- Primary completion
- 2025-04
- Completion
- 2025-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Subject | QL2109 | Monoclonal antibody | 1800 mg | Subcutaneous |