Actively Recruiting
A Phase I Clinical Study of GS3-007a Dry Suspensions in Healthy Chinese Adults Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalation, and Food Effect Study
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-03-16
32
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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 drug's effects in controlled conditions.
CONDITIONS
Brief 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, healthy adult males and females
- Body Mass Index (BMI) between 19 and 26 kg/m²
- Males weighing at least 50 kg, females weighing at least 45 kg
- Understand and voluntarily consent to the trial procedures and possible side effects
- Agree to use reliable non-drug contraception and avoid conception or sperm/egg donation from screening until 3 months after the last dose
You will not qualify if you...
- History of severe allergies
- History of neurological or psychiatric disorders or impaired cognitive or behavioral function
- Abnormal ECG QTcF interval or history of prolonged QT/QTc interval
- Abnormal liver function or clinically significant abnormal physical or laboratory findings
- History of hepatitis B, hepatitis C, syphilis, AIDS, or positive infectious disease screening
- Alcohol abuse or regular alcohol use within 6 months, or unwillingness to avoid alcohol during the trial
- Heavy smoking history or smoking 5 or more cigarettes per day within 3 months before screening
- Immune deficiencies, immunosuppressive diseases, malignant tumors, or chronic diseases of cardiovascular, liver, kidney, endocrine, respiratory, hematological, or digestive systems
- Major surgery within 6 months before screening or acute diseases within 3 months before screening
- Blood donation of 400 mL or more within 3 months before first dose
- Participation in other clinical trials or use of investigational drugs within 3 months before screening
- Abnormal diet or special dietary requirements incompatible with the study diet
- Pregnancy or breastfeeding in female participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days
Participants receive GS3-007a dry suspension or placebo in single and multiple dose regimens to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits during dosing up to 21 days
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
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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