A Clinical Study of GenSci134 in Healthy Male Adults

GeneScience Pharmaceuticals (GenSci)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: GenSci134; Drug: Recombinant Human Growth Hormone Injection (Norditropin®); Drug: GenSci134 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07016802

GenSci134-101

Details and patient eligibility

About

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

Full 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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 3 patient groups, including a placebo group

GenSci134

Experimental group

Treatment:

Drug: GenSci134

GenSc134 Placebo

Placebo Comparator group

Treatment:

Drug: GenSci134 Placebo

Recombinant Human Growth Hormone Injection (Norditropin®)

Active Comparator group

Treatment:

Drug: Recombinant Human Growth Hormone Injection (Norditropin®)