Actively Recruiting
A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2026-04-07
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.
CONDITIONS
Official Title
A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 55 years old at the time of signing the informed consent form
- Males with body weight at least 50 kg, females with body weight at least 45 kg
- Body mass index (BMI) between 19 and 28 kg/m²
- Female participants must be non-pregnant or not of childbearing potential
- Participants must understand study procedures, voluntarily agree to participate, and sign the informed consent form in person
You will not qualify if you...
- History of significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Known or suspected hypersensitivity to the trial product or related products
- 12-lead ECG showing QTcF greater than 450 msec or history/risk factors for QT prolongation
- Blood donation of more than 200 mL within the last 6 months
- Use of prescription, nonprescription drugs, or dietary/herbal supplements within 14 days or 7 half-lives
- Positive screening tests for hepatitis B or C, HIV, alcohol, or drugs of abuse
- Previous use of an investigational drug or vaccine within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yuanyuan Huang
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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