A Clinical Study of GZR33 and GZR101 in Healthy Subjects

Sponsor
Gan and Lee Pharmaceuticals, USA
Study ID
NCT06556641
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • GZR33 Injection — DRUG
    Administered as once daily subcutaneous dose
  • GZR101 Injection — DRUG
    Administered as once daily subcutaneous dose
  • Placebo — DRUG
    Administered as once daily subcutaneous dose
  • Insulin Degludec — DRUG
    Administered as once daily subcutaneous dose

Study Details

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.

Key Dates

Start date
Dec 17, 2022
Status verified
Aug 2024
Primary completion
Feb 3, 2023
Completion
Feb 3, 2023

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Part A : randomized, open-label, single-dose, two-sequence, two-period, cross-over Single administration of GZR33, washout period of 14 days, followed by single administration of Insulin Degludec Single administration of Insulin Degludec, washout period of 14 days, followed by single administration of GZR33
  • Experimental: Part B
    Part B: randomized, double-blind, placebo-controlled, multiple-dose, parallel Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c. Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c.

Primary Outcome Measure

AUC0-24h [ Time Frame: From 0 to 24 hours ]

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