A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults
ConditionHealthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;
Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;
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;
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.).
Disqualifiers
A highly allergic constitution
Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.
Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged; abnormal liver function; abnormal findings in physical examination, laboratory tests, or other examinations with clinical significance.
Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.
Trial design
Treatments tested in this trial
- GS3-007a for Suspension
- Placebo GS3-007a for Suspension
Treatment groups
32 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov