GS3-007a Oral Solution in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subject
• Interventions: Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication

• Registration Number: NCT05611281
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2022-09-22
• Study First Submitted: 2022-09-29
• Status Verified: 2022-10
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-10
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo GS3-007 oral liquid	GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication	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
GS3-007 oral liquid	GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication	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.

Primary Outcome Measures

Name	Time	Method
TEAEs	Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;	Adverse events during treatment：Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

Secondary Outcome Measures

Name	Time	Method
PK characteristics	Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;	To evaluate the pharmacokinetic (Peak Plasma Concentration (Cmax)) characteristics of GS3-007A in Chinese healthy adults after single, multiple, and single oral administration of high-fat meals.

Trial Locations

Locations (1)

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College; 🇨🇳 Chengdu, Chengdu, China