Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of RSS0343 After Multiple Oral Doses in Healthy Adults, Including Effects on QT/QTc Interval
Led by Reistone Biopharma Company Limited · Updated on 2026-01-14
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes RSS0343 after multiple oral doses in healthy adults aged 18 to 55 years. This phase I clinical trial also monitors the effects of RSS0343 on heart electrical activity, specifically the QT/QTc interval. Participants will receive either RSS0343 tablets or placebo tablets, taken orally, in a randomized and double-blind manner. The study observes the effects over a 28-day period, assessing the drug's concentration in the blood at various times and its elimination from the body. During the study, participants will undergo physical exams, vital signs checks, lab tests, and heart monitoring. Researchers will track any adverse events, measure drug levels in blood and urine, and monitor changes in heart rhythm. The study includes close safety monitoring throughout the 28-day evaluation period.
CONDITIONS
Brief Title
A Clinical Study of RSS0343 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent after full information about 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
- Fertile participants and partners agree to use highly effective contraception during and after the study
- Fertile females must have a negative pregnancy test 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 use above specified limits or positive alcohol test at baseline
- History or current drug abuse or positive urine drug screening
- Blood donation or blood loss above specified amounts within months before dosing or recent blood transfusion
- Difficulty swallowing, needle or blood phobia, poor venous access, or inability to tolerate blood draws
- Clinically significant abnormalities in physical exams, vital signs, lab tests, imaging, or ECG
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Known or suspected allergy to the drug or severe allergic reactions
- Active autoimmune disease or immunodeficiency
- Severe clinical disease or conditions affecting drug processing or safety
- Recent surgery within 3 months before screening or planned surgery during or soon after the trial
- Investigator judgment of unsuitability for the trial for any other reason
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 28 days
Participants receive multiple oral doses of RSS0343 or placebo to evaluate safety, tolerability, and pharmacokinetics.
Several visits during dosing period for assessments
Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
Research Team
Y
Ye Xu
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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