To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 1

Conditions: Healthy Subject

Treatments: Drug: GS3-007 oral liquid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05921890

GenSci073-104

Details and patient eligibility

About

To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.

Full description

To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult subjects aged 18-45 years (including boundary values), male or female;
• Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;

Exclusion criteria

• (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation;
• (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment;
• ALT and AST exceed the upper limit of the normal range;

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

GS3-007 oral liquid

Experimental group

Description:

36 subjects，12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks.

Treatment:

Drug: GS3-007 oral liquid