A Study of GZR4 Injection at Different Injection Sites

Phase 1

Recruiting

• Conditions: Healthy Subjects
• Interventions: Drug: GZR4 Injection

• Registration Number: NCT06548906
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

Brief Summary

This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-08
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• 1. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
• 2. A Male adult subjects aged 18-55 years old.
• 3. Body mass index (BMI) between 19.0-24.0 kg/m2

Exclusion Criteria

• 1. Known or suspected hypersensitivity to investigational medical product(s) or related products.
• 2. Participation in a clinical study of another study drug within 3 months prior to randomization.
• 3. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
• 4. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
• 5. More than 14 units of alcohol per week within 3 months prior to randomization
• 6. Smoking more than 5 cigarettes per day within 3 months prior to randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GZR4 Injection- Abdomen	GZR4 Injection	Participants received GZR4 Injection by subcutaneous injection on Abdomen.
GZR4 Injection- Upper Arm	GZR4 Injection	Participants received GZR4 Injection by subcutaneous injection on Upper Arm.
GZR4 Injection- Thigh	GZR4 Injection	Participants received GZR4 Injection by subcutaneous injection on Thigh.

Primary Outcome Measures

Name	Time	Method
AUC0-672h	From Predose to 672 hours after a single dose	Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours

Secondary Outcome Measures

Name	Time	Method
AUC0-∞	From Predose to 672 hours after a single dose	Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to Infinity
Cmax	From Predose to 672 hours after a single dose	Maximum Concentration of GZR4 Injection

Trial Locations

Locations (1)

Study Site; 🇨🇳 Beijing, China