Actively Recruiting
A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-03-16
32
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible
- Body Mass Index (BMI) between 19 and 26 kg/m² (inclusive)
- Males weighing at least 50 kg, females weighing at least 45 kg
- Fully understand the purpose, nature, and methods of the trial, and possible adverse reactions
- Voluntarily participate and sign the informed consent form before any study procedures
- Agree to use reliable non-drug contraception from screening day to 3 months after last dose and have no plans for conception or sperm/egg donation during this period
You will not qualify if you...
- Highly allergic constitution
- History of neurological or psychiatric disorders or lacking behavioral or cognitive function
- Abnormal ECG QTcF interval or history of QT/QTc prolongation
- Abnormal liver function or clinically significant abnormal findings in physical exam, lab tests, or other examinations
- History of hepatitis B, hepatitis C, syphilis, AIDS, or clinically significant infectious disease screening abnormalities
- Alcoholism or regular alcohol consumption within 6 months before first dose, or unwillingness to avoid alcohol during trial
- History of heavy smoking or smoking an average of 5 or more cigarettes per day within 3 months before screening
- Immune deficiencies, immunosuppressive diseases, malignant tumors, or chronic cardiovascular, liver, kidney, endocrine, respiratory, hematological, or digestive diseases
- Major surgery within 6 months before screening or during screening period
- Acute neurological, digestive, respiratory, circulatory, endocrine, or hematological diseases within 3 months before screening
- Blood donation or blood loss of 400 mL or more within 3 months before first dose
- Participation in any clinical trial using investigational drugs, vaccines, or devices within 3 months before screening
- Significant abnormal diet started within 4 weeks prior to or during screening, special dietary requirements, inability to comply with standardized diet, or intolerance to high-fat, high-calorie meal in postprandial trials
- Female subjects who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yuehong Plaza, No. 88 Hongcao Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
Research Team
H
Hong Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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