A Study of GZR4 Injection at Different Injection Sites

A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06548906

Enrollment

Registered

2024-08-12

Start date

2024-05-08

Completion date

2024-08-31

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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).

Interventions

DRUGGZR4 Injection

GZR4 Injection administered sc, once weekly.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary Contactwei zhao, PhD

wei.zhao@ganlee.com01056456746

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026