Actively Recruiting
A Phase 1 Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Bioavailability of HRS-6257 in Healthy Subjects
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2026-04-07
80
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, how the body processes, and the effects of food on the oral drug HRS-6257 in healthy adults aged 18 to 55. This phase 1, randomized, single-blind, placebo-controlled study aims to gather detailed information about how single and multiple doses of HRS-6257 behave in the body and their impact on pain tolerance. Participants will receive either HRS-6257 or a placebo in two parts of the study. The drug is given orally in single and repeated doses to assess its pharmacokinetics and pharmacodynamics. The study includes measurements over time to observe the drug's absorption and effects, including the influence of food on its bioavailability. During the study, participants will be monitored for adverse events from the day they sign consent until Day 14, 21, or 27 depending on the study part. Researchers will assess drug levels in the blood up to 72 hours after dosing, measure pain tolerance using the Cold Pain Test, and evaluate responses related to suicide risk. The total participation involves multiple visits for drug administration and safety evaluations to ensure careful monitoring throughout the trial.
CONDITIONS
Brief 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 (based on the time of signing the informed consent form), both males and females are eligible.
- Body weight of males 65 50 kg, and females 65 45 kg, with body mass index (BMI) between 19 and 28 kg/m�b2.
- Female subjects must be non-pregnant or non-childbearing potential.
- Subjects must understand the study procedures and methods, voluntarily participate, and sign the informed consent form in person.
You will not qualify if you...
- History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- Known or suspected hypersensitivity to the trial product(s) or related products.
- 12-lead ECG demonstrating QTcF >450 msec or history or risk factors for QT prolongation.
- Blood donation of more than 200 mL within the last 6 months.
- Use of prescription or nonprescription drugs and dietary or herbal supplements within 14 days or 7 half-lives.
- Positive screening tests for hepatitis B or C, HIV, alcohol, or drugs of abuse.
- Previous administration with an investigational product (drug or vaccine) within 3 months.
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.
Duration - Up to 27 days
Participants receive single or multiple doses of HRS-6257 or placebo to evaluate safety, tolerability, and drug effects.
1 to 3 visits depending on dosing schedule
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
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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