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Clinical Trials in China / NCT07670897
Starting soon Phase 1

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

NCT07670897 · tracked via the Priya Life Science China tracker
Sponsor
Gan & Lee Pharmaceuticals.
Phase
Phase 1
Started
2026-07-01
Last updated
2026-06-26

Condition(s) studied

T2D

Investigational drug(s) / intervention(s)

GZR4 injection AGZR4 injection B

GZR4 injection A: GZR4 s.c., single-dose

GZR4 injection B: GZR4 s.c., single-dose

Study summary

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Gan & Lee Pharmaceuticals Shandong Co., Ltd., Linyi Shandong

More Gan & Lee Pharmaceuticals. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07670897 on ClinicalTrials.gov ↗ ← All trials in China