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

Starting soon · Phase 1

Conditions studied: T2D

In brief

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

Key facts

Study ID

NCT07670897

Run by

Gan & Lee Pharmaceuticals.

People needed

64

Starts

2026-07-01

Expected to finish

2026-07-29

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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…

• 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.
• 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.

Where it is running

• Gan & Lee Pharmaceuticals Shandong Co., Ltd., — Linyi, Shandong, China

Full record on ClinicalTrials.gov

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