A Study of GZR4 Injection at Different Injection Sites

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2024-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GZR4 Injection- Abdomen

Participants received GZR4 Injection by subcutaneous injection on Abdomen.

Group Type EXPERIMENTAL

GZR4 Injection

Intervention Type DRUG

GZR4 Injection administered sc, once weekly.

GZR4 Injection- Upper Arm

Participants received GZR4 Injection by subcutaneous injection on Upper Arm.

Group Type EXPERIMENTAL

GZR4 Injection

Intervention Type DRUG

GZR4 Injection administered sc, once weekly.

GZR4 Injection- Thigh

Participants received GZR4 Injection by subcutaneous injection on Thigh.

Group Type EXPERIMENTAL

GZR4 Injection

Intervention Type DRUG

GZR4 Injection administered sc, once weekly.

Interventions

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GZR4 Injection

GZR4 Injection administered sc, once weekly.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes