GS3-007a Oral Solution in Healthy Subjects

Changchun GeneScience Pharmaceutical Co., Ltd.96 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Healthy Subject

Interventions

GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medicationDRUG

The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College

Chengdu, Chengdu, China

Outcomes

Primary Outcomes

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.

Time frame: 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

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.

Time frame: 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;

Data from ClinicalTrials.gov

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