Menu
Recruiting NCT06548906

A Study of GZR4 Injection at Different Injection Sites

Phase I Interventional Healthy Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GZR4 Injection.
Who it may be relevant to
Registry conditions: Healthy Subjects. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug GZR4 Injection
    GZR4 Injection administered sc, once weekly.

Primary outcome measures

  • AUC0-672h [Time frame: From Predose to 672 hours after a single dose]
Secondary outcome measures (2)
  • AUC0-∞ [Time frame: From Predose to 672 hours after a single dose]
  • Cmax [Time frame: From Predose to 672 hours after a single dose]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Study Site — Beijing

Identifiers

NCT: NCT06548906 · GZR4-T2D-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗