drugset / Trial / NCT06974487
A Phase I Study to Evaluate the PK and PD Profiles of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects
RandomizedCrossoverQuadruple-blindTreatment
Summary
This trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately. Subjects undergo a screening phase of up to 3 weeks (D-21 to D-3). Eligible subjects are randomized in a 1:1:1:1:1:1 ratio into six dosing sequences, receiving single doses of GZR102 injection, GZR4 injection, and GZR18 injection across 3 cycles. A washout period of at least 1 week separates each cycle.
Timeline
- Start
- 2025-05-08
- Primary completion
- 2025-09-30
- Completion
- 2025-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bofanglutide | Protein / enzyme biologic | — | — |
| Subject | GZR102 | Unknown | — | — |
| Comparator | GZR4 | Unknown | — | — |