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A Clinical Study of GZR33 and GZR101 in Healthy Subjects

NCT06556641 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gan and Lee Pharmaceuticals, USA

    lead INDUSTRY

Principal Investigators

  • Clinical Transparency · Gan & Lee Pharmaceuticals.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-17
Primary Completion
2023-02-03
Completion
2023-02-03

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556641 on ClinicalTrials.gov