A Clinical Study of GenSci134 in Healthy Male Adults

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: GenSci134; Drug: GenSci134 Placebo; Drug: Recombinant Human Growth Hormone Injection (Norditropin®)

• Registration Number: NCT07016802
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

GenSci134 was tested in 7 predetermined dose groups with placebo and positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 64 healthy adult male subjects

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-06-09
• Study First Posted: 2025-06-12
• Study Start: 2025-06-23
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-04-13
• Study Completion: 2026-04-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 major surgery within 12 months prior to screening;
• Subjects with a history of neoplastic diseases;
• Subjects who have participated in any other clinical trial of drugs or medical devices and have used the investigational medicinal product within 28 days or 5 half-lives (whichever is longer) before dosing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GenSci134	GenSci134	-
GenSc134 Placebo	GenSci134 Placebo	-
Recombinant Human Growth Hormone Injection (Norditropin®)	Recombinant Human Growth Hormone Injection (Norditropin®)	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events and serious adverse events	36 days

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China