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

NCT ID: NCT06548932

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-02-24

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GZR33 Injection

Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)

Group Type: EXPERIMENTAL

GZR33 Injection

Intervention Type: DRUG

A single dose

Placebo

Intervention Type: DRUG

A single dose

GZR101 Injection

Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)

Group Type: EXPERIMENTAL

GZR101 Injection

Intervention Type: DRUG

A single dose

Placebo

Intervention Type: DRUG

A single dose

Interventions

GZR33 Injection

A single dose

Intervention Type: DRUG

GZR101 Injection

A single dose

Intervention Type: DRUG

Placebo

A single dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency

Role: STUDY_DIRECTOR

Gan & Lee Pharmaceuticals.

Locations

Study Site 01

Tianjin, , China

Countries

China

Other Identifiers

GL-GZR-CH1006

Identifier Type: -

Identifier Source: org_study_id