A Clinical Study of GenSci134 in Healthy Male Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2026-04-13

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GenSci134

Group Type EXPERIMENTAL

GenSci134

Intervention Type DRUG

only one dose of GenSci134 and GenSci134 Placebo to be given, subcutaneous , 7 dose levels will be assigned.

GenSc134 Placebo

Group Type PLACEBO_COMPARATOR

GenSci134 Placebo

Intervention Type DRUG

only one dose of GenSci134 and GenSci134 Placebo to be given, subcutaneous , 7 dose levels will be assigned.

Recombinant Human Growth Hormone Injection (Norditropin®)

Group Type ACTIVE_COMPARATOR

Recombinant Human Growth Hormone Injection (Norditropin®)

Intervention Type DRUG

A single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days.

Interventions

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GenSci134

only one dose of GenSci134 and GenSci134 Placebo to be given, subcutaneous , 7 dose levels will be assigned.

Intervention Type DRUG

GenSci134 Placebo

only one dose of GenSci134 and GenSci134 Placebo to be given, subcutaneous , 7 dose levels will be assigned.

Intervention Type DRUG

Recombinant Human Growth Hormone Injection (Norditropin®)

A single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes