Actively Recruiting
A Clinical Study of RSS0343 in Healthy Subjects
Led by Reistone Biopharma Company Limited · Updated on 2026-01-14
48
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.
CONDITIONS
Official Title
A Clinical Study of RSS0343 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent after understanding the trial
- Healthy males and females aged 18 to 55 years
- Body weight at least 50 kg for males and 45 kg for females
- Body mass index between 19 and 28 kg/m² inclusive
- Fertile participants and their partners agree to use highly effective contraception during and after the study
- Fertile females must have a negative pregnancy test at screening and before dosing and must not be breastfeeding
You will not qualify if you...
- Smoked more than 5 cigarettes or equivalent nicotine products daily within 3 months before screening or plan to use tobacco during the trial
- Frequent alcohol consumption exceeding defined limits within 6 months before screening or unable to abstain during the trial
- History or current drug abuse or positive drug screening
- Donated blood or had significant blood loss within 1 to 3 months before dosing or received blood transfusion within 8 weeks
- Have difficulty swallowing, needle or blood phobia, poor venous access, or cannot tolerate venipuncture
- Clinically significant abnormalities in physical exam, vital signs, lab tests, chest imaging, abdominal ultrasound, or ECG
- Positive for hepatitis B, hepatitis C, syphilis, or HIV antibodies
- Known or suspected allergy to the investigational drug or its components
- Active autoimmune disease or immunodeficiency at screening
- History of severe clinical disease or conditions that could affect drug metabolism or pose risk
- Recent surgery within 3 months before screening not fully recovered or planned surgery during or within 1 month after study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
Research Team
Y
Ye Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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