NCT06548997

A Phase I Study of GZR18 Injection in Healthy Subjects

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.

Conditions

• Type 2 Diabetes
• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	GZR18	5 μg/kg-maximum tolerated dose (MTD), single dose or two doses
OTHER	Placebo	administered the same volume as GZR18

Timeline

• Start date: 2021-12-02
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2024-08-12
• Last updated: 2024-08-14

Locations

1 site across 1 country: China