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

G

Gan and Lee Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Placebo
Drug: GZR101 Injection
Drug: GZR33 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06548932
GL-GZR-CH1006

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

    1. Voluntarily participated in the study and signed the informed consent form (ICF);
    1. 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;
    1. 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;
    1. 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;
    1. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 2 patient groups

GZR33 Injection
Experimental group
Description:
Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)
Treatment:
Drug: GZR33 Injection
Drug: Placebo
GZR101 Injection
Experimental group
Description:
Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)
Treatment:
Drug: GZR101 Injection
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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