NCT06548932

A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance, PK and PD Parameters of Single Dose Escalation of GZR33 and Single Administration of GZR101 in Healthy Male Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	GZR33 Injection	A single dose
DRUG	GZR101 Injection	A single dose
DRUG	Placebo	A single dose

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2024-08-12
• Last updated: 2024-08-16

Locations

1 site across 1 country: China