NCT06556641

A Clinical Study of GZR33 and GZR101 in Healthy Subjects

Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B. Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection. Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	GZR33 Injection	Administered as once daily subcutaneous dose
DRUG	GZR101 Injection	Administered as once daily subcutaneous dose
DRUG	Placebo	Administered as once daily subcutaneous dose
DRUG	Insulin Degludec	Administered as once daily subcutaneous dose

Timeline

• Start date: 2022-12-17
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: China