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NCT07301333
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
Phase 1 trial testing HRS-6257 in Pain in 80 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 30 December 2025 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 May 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- HRS-6257 — full drug profile →
- placebo
Conditions studied
- Pain — all drugs for Pain →
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Pain. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The incidence and severity of adverse events
Time frame: from ICF signing date to Day 14 or Day 21 or Day 27
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07301333
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Hengrui Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06877247 — A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism · Phase 1 · completed
- NCT06649292 — SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or M · Phase 3 · recruiting
- NCT06654440 — A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy · Phase 2 · recruiting
- NCT06639347 — A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma · Phase 1, PHASE2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07301333 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Hengrui Pharmaceutical Co., Ltd.
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07301333.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing