A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: GZR33 Injection; Drug: GZR101 Injection; Drug: Placebo

• Registration Number: NCT06548932
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

Brief Summary

This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Primary Completion: 2023-02-24
• Study Completion: 2023-02-24
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

• 1. Voluntarily participated in the study and signed the informed consent form (ICF);
• 2. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
• 3.Body mass index [BMI= weight (kg)/height (m) 2] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；

Exclusion Criteria

• 1. Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;
• 2. Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;
• 3. Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;
• 4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;
• 5. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GZR33 Injection	GZR33 Injection	Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)
GZR33 Injection	Placebo	Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)
GZR101 Injection	GZR101 Injection	Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)
GZR101 Injection	Placebo	Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AE)	From Predose to Day14 after a single dose	Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.

Secondary Outcome Measures

Name	Time	Method
AUCIAsp，0-12 h	From 0 hours to 12 hours after a single dose	Area under the plasma concentration curve of insulin aspart from 0 to 12 hours
GIRmax	From 0 hours to 24 hours after a single dose	Maximum glucose infusion rate
AUCGZR33,0-24 h	From Predose to Day8 after a single dose	Area under the plasma concentration curve of GZR33 from 0 to 24 hours

Trial Locations

Locations (1)

Study Site 01; 🇨🇳 Tianjin, China