Pain
Conditions
Brief summary
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
DRUGHRS-6257
HRS-6257
DRUGplacebo
placebo
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible. 2. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m². 3. Female subjects must be non-pregnant or non-childbearing potential; 4. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.
Exclusion criteria
1. History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease; 2. Known or suspected hypersensitivity to trial product(s) or related products; 3. 12-lead ECG demonstrating QTcF \>450 msec or history or risk factors for QT prolongation; 4. Blood donation of more than 200 mL within the last 6 months 5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 7 half-lives; 6. Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse. 7. Previous administration with an investigational product (drug or vaccine) within 3 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | from ICF signing date to Day 14 or Day 21 or Day 27 |
Secondary
| Measure | Time frame |
|---|---|
| AUC of HRS-6257 | 0 hour to 72 hour after administration |
| Cmax of HRS-6257 | 0 hour to 72 hour after administration |
| Tmax of HRS-6257 | 0 hour to 72 hour after administration |
| t1/2 of HRS-6257 | 0 hour to 72 hour after administration |
| CL/F of HRS-6257 | 0 hour to 72 hour after administration |
| Vz/F of HRS-6257 | 0 hour to 72 hour after administration |
| Pain tolerance time for the Cold Pain Test | Day 1 to Day 1 or Day 14 |
| Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | from ICF signing date to Day 14 |
Countries
China
Outcome results
None listed