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

NCT06974487

Phase 1 Not yet recruiting 30 enrolled Gan & Lee Pharmaceuticals.
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

EvaluationDrugModalityDoseRoute
Comparator Bofanglutide Protein / enzyme biologic
Subject GZR102 Unknown
Comparator GZR4 Unknown