A Study of GZR4 Injection at Different Injection Sites

NCT06548906 | Recruiting Phase 1

• 1 other identifier: GZR4-T2D-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• AUC0-672h

  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 Outcomes (2)

• AUC0-∞

  From Predose to 672 hours after a single dose

• Cmax

  From Predose to 672 hours after a single dose

Study Arms (3)

GZR4 Injection- Abdomen

EXPERIMENTAL

Participants received GZR4 Injection by subcutaneous injection on Abdomen.

Drug: GZR4 Injection

GZR4 Injection- Upper Arm

EXPERIMENTAL

Participants received GZR4 Injection by subcutaneous injection on Upper Arm.

Drug: GZR4 Injection

GZR4 Injection- Thigh

EXPERIMENTAL

Participants received GZR4 Injection by subcutaneous injection on Thigh.

Drug: GZR4 Injection

Interventions

GZR4 Injection DRUG

GZR4 Injection administered sc, once weekly.

GZR4 Injection- Abdomen; GZR4 Injection- Thigh; GZR4 Injection- Upper Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. A Male adult subjects aged 18-55 years old.
• \. Body mass index (BMI) between 19.0-24.0 kg/m2

You may not qualify if:

• \. Known or suspected hypersensitivity to investigational medical product(s) or related products.
• \. Participation in a clinical study of another study drug within 3 months prior to randomization.
• \. 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.
• \. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
• \. More than 14 units of alcohol per week within 3 months prior to randomization
• \. Smoking more than 5 cigarettes per day within 3 months prior to randomization

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Study Site

Beijing, China

RECRUITING

Study Officials

• Clinical Transparency

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Central Study Contacts

wei zhao, PhD

CONTACT

01056456746; wei.zhao@ganlee.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: May 8, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)