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NCT03769831
The PK/PD Study of SHR2285 Tablets in Healthy Subjects
Phase 1 trial testing SHR2285 in Thrombosis in 28 participants. Completed in 22 July 2019.
22 July 2019
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 28 |
| Start date | 25 February 2019 |
| Primary completion | 22 July 2019 |
| Estimated completion | 22 July 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR2285
- Placebo
Conditions studied
- Thrombosis — all drugs for Thrombosis →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Thrombosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
First-In-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, a Small-Molecule Factor XIa Inhibitor in Healthy Subjects.
Chen R, Guan X, Hu P, Dong Y, et al · · 2022 · cited 14× · PMID 35222036 · DOI 10.3389/fphar.2022.821363 -
Factor XIa Inhibitors as a Novel Anticoagulation Target: Recent Clinical Research Advances.
Xia Y, Hu Y, Tang L. · · 2023 · cited 12× · PMID 37375813 · DOI 10.3390/ph16060866 -
Factor XI, a potential target for anticoagulation therapy for venous thromboembolism.
Li T, Liu J, Wu W. · · 2022 · cited 4× · PMID 36386334 · DOI 10.3389/fcvm.2022.975767
Verify or expand the search:
- PubMed search for NCT03769831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SHR2285
Trials testing the same drug.
- NCT04829305 — A Trial of SHR2285 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 NCT03769831 (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: 24 May 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/NCT03769831.
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