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 or Placebo GS3-007 oral liquid oral medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT05611281

GenSci073-101

Details and patient eligibility

About

To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

Full description

This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended

Enrollment: 96 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 and female;
• Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;

Exclusion criteria

• Patients with a history of substance abuse and substance dependence;
• Family history of sudden death;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

GS3-007 oral liquid

Experimental group

Description:

78 subjects: Part 1 SAD 36 subjects: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose. Part 2 MAD 30 subjects: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days Part 3 Food effects 12 subjects: Planned in 1.6mg/kg dose group。Once a day, a total of one dose.

Treatment:

Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication

Placebo GS3-007 oral liquid

Placebo Comparator group

Description:

Part 1 SAD: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose. Part 2 MAD: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days

Treatment:

Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication