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

A Randomized, Double-Blind, Crossover Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD Profiles of a Single Dose of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	GZR102 injection	Participants will get a single dose of GZR102 injection （fixed-ratio combination of GZR4 and GZR18）.
DRUG	GZR4 injection	Participants will get a single dose of GZR4 injection
DRUG	GZR18 injection	Participants will get a single dose of GZR18 injection

Timeline

• Start date: 2025-05-08
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: China