GS3-007a Oral Solution in Healthy Subjects

Healthy Subject Clinical Trial

Official title:

Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611281
• Other study ID #: GenSci073-101
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2022
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Drug:
• GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication
The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Locations

Country	Name	City	State
China	Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College	Chengdu	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEAEs	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.	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;
Secondary	PK characteristics	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.	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;