A Single-center, Single-administration, Randomized, Placebo-controlled, Dose-escalation Trial Evaluated the Safety, Tolerability, PK, and PD Parameters of GZR4 in Healthy Male Adult Subjects

Gan and Lee Pharmaceuticals, USA1 site in 1 country43 target enrollmentAugust 29, 2022

ConditionsDiabetes

InterventionsGZR4 Placebo

DrugsGZR4 Placebo

Overview

Phase: Phase 1
Intervention: GZR4
Conditions: Diabetes
Sponsor: Gan and Lee Pharmaceuticals, USA
Enrollment: 43
Locations: 1
Primary Endpoint: Incidence of TEAE
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 29, 2022

End Date

March 24, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Gan and Lee Pharmaceuticals, USA

Responsible Party

Sponsor

Eligibility Criteria

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