A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-6257, placebo.
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug HRS-6257
HRS-6257 - Drug placebo
placebo
Primary outcome measures
- The incidence and severity of adverse events [Time frame: from ICF signing date to Day 14 or Day 21 or Day 27]
Secondary outcome measures (8)
- AUC of HRS-6257 [Time frame: 0 hour to 72 hour after administration]
- Cmax of HRS-6257 [Time frame: 0 hour to 72 hour after administration]
- Tmax of HRS-6257 [Time frame: 0 hour to 72 hour after administration]
- t1/2 of HRS-6257 [Time frame: 0 hour to 72 hour after administration]
- CL/F of HRS-6257 [Time frame: 0 hour to 72 hour after administration]
- Vz/F of HRS-6257 [Time frame: 0 hour to 72 hour after administration]
- Pain tolerance time for the Cold Pain Test [Time frame: Day 1 to Day 1 or Day 14]
- Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses [Time frame: from ICF signing date to Day 14]
Eligibility criteria
Inclusion criteria
- Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.
- The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m².
- Female subjects must be non-pregnant or non-childbearing potential;
- Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.
Exclusion criteria
- History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;
- Known or suspected hypersensitivity to 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 and herbal supplements within 14 days or 7 half-lives;
- Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse.
- Previous administration with an investigational product (drug or vaccine) within 3 months;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Third Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT07301333 · HRS-6257-101