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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: GZR4; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Gan & Lee Pharmaceuticals Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GZR4; s.c, single dose	Drug: GZR4; Ascending single doses - 4 dose levels.
Placebo Comparator: Placebo; s.c, single dose	Drug: Placebo; Ascending single doses - 4 dose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of TEAE	Baseline to Day29

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: PK; GZR4
• Other Study ID Numbers: GL-GZR-CH1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes