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

NCT06548932 | Completed Phase 1

• 1 other identifier: GL-GZR-CH1006
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AE)

  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.

  From Predose to Day14 after a single dose

Secondary Outcomes (3)

• GIRmax

  From 0 hours to 24 hours after a single dose

• AUCGZR33,0-24 h

  From Predose to Day8 after a single dose

• AUCIAsp，0-12 h

  From 0 hours to 12 hours after a single dose

Study Arms (2)

GZR33 Injection

EXPERIMENTAL

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

Drug: GZR33 Injection; Drug: Placebo

GZR101 Injection

EXPERIMENTAL

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

Drug: GZR101 Injection; Drug: Placebo

Interventions

GZR33 Injection DRUG

A single dose

GZR33 Injection

GZR101 Injection DRUG

A single dose

GZR101 Injection

Placebo DRUG

A single dose

GZR101 Injection; GZR33 Injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Voluntarily participated in the study and signed the informed consent form (ICF);
• \. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
• 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；

You may not qualify if:

• \. 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;
• \. 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;
• \. 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;
• 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;
• \. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Study Site 01

Tianjin, China

Location

Study Officials

• Clinical Transparency

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: June 30, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)