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

NCT07670897 | Not Yet Recruiting Phase 1

• 1 other identifier: GZR4-T2D-106
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

T2D

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Tmax

  Day1-Day29

• t1/2

  Day1-Day29

• AUC_%Extrap

  Day1-Day29

Study Arms (2)

GZR4 injection A

EXPERIMENTAL

Drug: GZR4 injection A

GZR4 injection B

EXPERIMENTAL

Drug: GZR4 injection B

Interventions

GZR4 injection A DRUG

GZR4 s.c., single-dose

GZR4 injection A

GZR4 injection B DRUG

GZR4 s.c., single-dose

GZR4 injection B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. Have special dietary requirements and are unable to comply with the standardized diet.
• \. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.
• \. 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.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Gan & Lee Pharmaceuticals Shandong Co., Ltd.,

Linyi, Shandong, 276000, China

Location

Central Study Contacts

Yunda Zhuge

CONTACT

010-56456739; zhugeyunda@ganlee.com

Shiyun Lai

CONTACT

010-56456739; shiyun.lai@ganlee.com

Study Design

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

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion: July 29, 2026
• Study Completion: July 29, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

CN (1)