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NCT04472819
The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects
Phase 1 trial testing SHR2285 tablet in Thrombosis in 104 participants. Completed in 31 May 2021.
31 May 2021
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 28 August 2020 |
| Primary completion | 31 May 2021 |
| Estimated completion | 31 May 2021 |
| Sites | 2 locations across China |
Drugs / interventions tested
- SHR2285 tablet — full drug profile →
- Placebo
Conditions studied
- Thrombosis — all drugs for Thrombosis →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Thrombosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is a randomized, doubled-blinded, placebo-controlled, Phase I trials. The study is divided into two parts. The first part is a single-dose escalated study (SAD,part 1A ) and food effect study (SAD, part 1B ) in healthy subjects. The second part is a multi-dose escalated study (MAD) in healthy subjects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, an Oral Small Molecule Factor XIa Inhibitor, in Healthy Chinese Volunteers.
Xu J, Zhao N, Huang J, Li J, et al · · 2023 · cited 2× · PMID 37326942 · DOI 10.1007/s40261-023-01281-8
Verify or expand the search:
- PubMed search for NCT04472819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SHR2285 tablet
Trials testing the same drug.
- NCT05203705 — Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Ele · Phase 2 · terminated
- NCT04229433 — The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Thrombosis
Currently open trials in the same condition.
- NCT07137429 — Platelet Volunteers, Longitudinal and Multi-omic Study · recruiting
- NCT06676904 — Neonatal Platelet Transfusion Threshold Trial · NA · recruiting
- NCT06993740 — Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient · NA · recruiting
- NCT07358416 — Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery. · active not recruiting
- NCT06370273 — Thromboprophylaxis in Lower Limb Immobilisation · Phase 3 · recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed
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 NCT04472819 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 28 September 2021
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/NCT04472819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing