NCT07301333 A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
| NCT ID | NCT07301333 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-12-30 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07301333 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07301333 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07301333 currently recruiting?
Yes, NCT07301333 is actively recruiting participants. Contact the research team at yuanyuan.huang@hengrui.com for enrollment information.
Where is the NCT07301333 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07301333 clinical trial?
NCT07301333 is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. The trial plans to enroll 80 participants.