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Recruiting Phase 1 NCT07016802

A Clinical Study of GenSci134 in Healthy Male Adults

Trial Parameters

Condition Healthy Volunteers
Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 64
Sex ALL
Min Age 18 Years
Max Age 45 Years
Start Date 2025-06-23
Completion 2026-04-13
Interventions
GenSci134GenSci134 PlaceboRecombinant Human Growth Hormone Injection (Norditropin®)

Brief Summary

To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers

Eligibility Criteria

Inclusion Criteria: * Healthy adult male subjects aged 18-45 years (inclusive of boundary values); * Body Mass Index (BMI): 19.0-24.0 kg/m² (inclusive of boundary values); * Good health status; * Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions. Exclusion Criteria: * Subjects with significant medical history or clinical manifestations determined by the investigator; * History of hypersensitivity, intolerance, or allergy to any drug, compound, food, or other substances, or known allergy to any excipients of the study drug; * History of neurological or psychiatric disorders, or subjects with impaired consciousness or cognitive dysfunction; * Subjects with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant; * Subjects with immunodeficiency or immunosuppressive diseases at screening; * Subjects who have undergone majo

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