Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants

A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants

This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.

Study Overview

• Status: Not yet recruiting
• Conditions: T2D
• Intervention / Treatment: Drug: GZR4 injection A; Drug: GZR4 injection B

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yunda Zhuge; Phone Number: 010-56456739; Email: zhugeyunda@ganlee.com
• Study Contact Backup: Name: Shiyun Lai; Phone Number: 010-56456739; Email: shiyun.lai@ganlee.com

Study Locations

• China
  • Shandong
    • Linyi, Shandong, China, 276000
      • Gan & Lee Pharmaceuticals Shandong Co., Ltd.,
      • Contact: Yunda Zhuge; Phone Number: 010-56456739; Email: zhugeyunda@ganlee.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Voluntarily sign the Informed Consent Form (ICF), be willing to accept subcutaneous injection, fully understand the study content, procedures and potential adverse reactions, and be able to comply with the contraindications and restrictions specified in this protocol.

  2. Male, aged 18 to 50 years (inclusive) at the time of ICF signing. 3. Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 24.0 kg/m² (inclusive) at screening.

  4. Male participants of childbearing potential have no plans for conception, voluntarily adopt effective contraceptive measures, and have no sperm donation plans from the date of ICF signing until 4 weeks after dosing.

Exclusion Criteria:

• 1. Have an allergic constitution, or a history of allergic diseases such as bronchial asthma and eczema (except for mild seasonal allergy); or have a history of severe food allergy (e.g., laryngeal edema, shock); or known allergy, hypersensitivity or intolerance to the investigational medicinal product (IMP) or similar products or their excipients; or have a clinically significant history of drug allergy or atopic allergic diseases.

  2. Findings from physical examination, vital signs, routine laboratory tests, 12-lead electrocardiogram (ECG), chest imaging and other assessments at screening are judged to be clinically significant by the investigator.

  3. Have special dietary requirements and are unable to comply with the standardized diet.

  4. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.

  5. The participant is an employee of the investigator or the study center, or a family member of an employee or the investigator; or the participant has other factors that, in the investigator's opinion, make him/her unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GZR4 injection A	Drug: GZR4 injection A; GZR4 s.c., single-dose
Experimental: GZR4 injection B	Drug: GZR4 injection B; GZR4 s.c., single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak concentration following single administration of GZR4	Day1-Day29
AUC₀-t	Area under the plasma concentration-time curve from time zero to the last quantifiable sampling time point t after single administration of GZR4	Day1-Day29
AUC₀-∞	Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4	Day1-Day29

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax	Day1-Day29
t1/2	Day1-Day29
AUC_%Extrap	Day1-Day29

Collaborators and Investigators

• Sponsor: Gan & Lee Pharmaceuticals.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 29, 2026
• Study Completion (Estimated): July 29, 2026

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GZR4-T2D-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No