PainPhase 1NCT07301333
A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
A Phase 1 study testing HRS-6257 in people with Pain, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- HRS-6257
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 16 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
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
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
- Pain
- Being tested
- HRS-6257, placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6257Drug
HRS-6257
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| HRS-6257 group | Experimental | Not described Receives: Drug: HRS-6257 |
| placebo group | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: from ICF signing date to Day 14 or Day 21 or Day 27
Secondary outcomes (8)
AUC of HRS-6257
Measured: 0 hour to 72 hour after administration
Cmax of HRS-6257
Measured: 0 hour to 72 hour after administration
Tmax of HRS-6257
Measured: 0 hour to 72 hour after administration
t1/2 of HRS-6257
Measured: 0 hour to 72 hour after administration
CL/F of HRS-6257
Measured: 0 hour to 72 hour after administration
Vz/F of HRS-6257
Measured: 0 hour to 72 hour after administration
Pain tolerance time for the Cold Pain Test
Measured: Day 1 to Day 1 or Day 14
Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Measured: from ICF signing date to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start30 Dec 2025
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301333
- Sponsor's protocol ID
- HRS-6257-101
- Status last verified
- Nov 2025
- First submitted
- 10 Dec 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07301333
- Acronym / sponsor ID
- HRS-6257-101
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-6257 group | Experimental | Drug: HRS-6257 |
| placebo group | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-6257HRS-6257 | Drug | HRS-6257 group |
| placeboplacebo | Drug | placebo group |
Primary outcome
The incidence and severity of adverse events
Time frame: from ICF signing date to Day 14 or Day 21 or Day 27
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-6257 in people with Pain, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (time frame: from ICF signing date to Day 14 or Day 21 or Day 27). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.