GS3-007a Oral Solution in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05611281

Enrollment

Registered

2022-11-10

Start date

2022-09-22

Completion date

2023-04-01

Last updated

2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subject

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

Interventions

DRUGGS3-007 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026