Phase I Study of GS3-007a Dry Suspension in Healthy Chinese Adults Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Including Food Effect Assessment

What this Trial Is About

Researchers are conducting a Phase I clinical trial to study GS3-007a dry suspension in healthy Chinese adults aged 18 to 45 years. This study has two parts a single-dose escalating and food effect phase, followed by a multiple-dose 14-day escalating phase. Both are randomized, double-blind, placebo-controlled dose-escalation studies designed to assess safety and pharmacokinetics. Participants will receive GS3-007a dry suspension or a matching placebo. The dry suspension is taken orally after reconstitution with water, with doses based on body weight. The study includes single ascending dose and food effect assessments lasting up to 6 days, followed by a multiple ascending dose phase lasting up to 21 days. The medication is stored protected from light and administered in sealed containers. During the trial, participants will undergo safety monitoring for treatment-emergent adverse events up to 6 days in the single-dose phase and up to 21 days in the multiple-dose phase. Pharmacokinetic and pharmacodynamic measurements will be collected over these periods. Participants will also complete physical exams, laboratory tests, and ECGs to monitor health. Total participation time varies with each study phase, and healthy volunteers are enrolled to evaluate the drugs effects in controlled conditions.

A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults