A Study(Phase I)of GS3-007a Dry Suspension in Healthy Chinese Adults
Trial Parameters
Brief Summary
This study consists of two parts: the first part is a single-dose escalating(SAD) and food effect (FE)study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible; 2. Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg; 3. Fully understand the purpose, nature, and methods of the trial, as well as possible adverse reactions, voluntarily participate as subjects, sign the informed consent form (ICF) before any study procedures; 4. From screening day to 3 months after the last dose, have no plans for conception or sperm/egg donation, and agree to use reliable non-drug contraception during the trial (such as complete abstinence, intrauterine device, partner sterilization, etc.). Exclusion Criteria: 1. A highly allergic constitution 2. Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function. 3. Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged; abnormal liver function; abnormal findings in physi