GS3-007a Oral Solution in Healthy Subjects | NCT05611281 | Trialant

GS3-007a Oral Solution in Healthy Subjects | NCT05611281 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GS3-007 oral liquid	Experimental	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.	Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication
Placebo GS3-007 oral liquid	Placebo Comparator	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	Drug: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication	Drug	The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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;

Contacts/Locations Module