A Study of GZR4 Injection at Different Injection Sites

August 8, 2024 updated by: Gan and Lee Pharmaceuticals, USA

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GZR4 Injection- Abdomen
Participants received GZR4 Injection by subcutaneous injection on Abdomen.
Drug: GZR4 Injection
GZR4 Injection administered sc, once weekly.
Experimental: GZR4 Injection- Upper Arm
Participants received GZR4 Injection by subcutaneous injection on Upper Arm.
Drug: GZR4 Injection
GZR4 Injection administered sc, once weekly.
Experimental: GZR4 Injection- Thigh
Participants received GZR4 Injection by subcutaneous injection on Thigh.
Drug: GZR4 Injection
GZR4 Injection administered sc, once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-672h
Time Frame: 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
From Predose to 672 hours after a single dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-∞
Time Frame: From Predose to 672 hours after a single dose
Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to Infinity
From Predose to 672 hours after a single dose
Cmax
Time Frame: From Predose to 672 hours after a single dose
Maximum Concentration of GZR4 Injection
From Predose to 672 hours after a single dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gan and Lee Pharmaceuticals, USA

Investigators

  • Study Director: Clinical Transparency, Gan&Lee Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • GZR4-T2D-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Subjects

Clinical Trials on GZR4 Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe