Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: Placebo; Drug: GZR4

• Registration Number: NCT06548815
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

Brief Summary

This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-29
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-24
• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

• Chinese healthy male adult subjects aged 18-45 years old
• Body mass index [BMI between 19.0-24.0 kg/m2
• Hemoglobin A1c (HbA1c)≤6%

Exclusion Criteria

• Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
• Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
• Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
• Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
• Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	s.c, single dose
GZR4	GZR4	s.c, single dose

Primary Outcome Measures

Name	Time	Method
Incidence of TEAE	Baseline to Day29

Secondary Outcome Measures

Name	Time	Method
AUC0-last	Baseline to Day29
T1/2	Baseline to Day29
GIRmax	Day2-Day3
Cmax	Baseline to Day29
Tmax,GZR4	Baseline to Day29
AUC0-inf	Baseline to Day29
Tmax,GIR	Day2-Day3
AUCGIR	Day2-Day3/Day7-Day8

Trial Locations

Locations (1)

Gan & Lee Pharmaceuticals Co., Ltd; 🇨🇳 Beijing, Beijing, China