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NCT04945616
To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
Phase 1 trial testing Aspirin、clopidogrel、placebo or SHR2285 in Thrombosis in 52 participants. Completed in 15 June 2022.
19 October 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 | other |
| Enrollment | 52 |
| Start date | 13 July 2021 |
| Primary completion | 19 October 2021 |
| Estimated completion | 15 June 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Aspirin、clopidogrel、placebo or SHR2285 — full drug profile →
- Aspirin、clopidogrel、placebo or SHR2285 — full drug profile →
- Aspirin、ticagrelor、placebo or SHR2285 — full drug profile →
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 single-center,randomized, doubled-blinded, placebo-controlled, Only for SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of groups A and B, and 20 cases in group C.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
SHR2285, the first selectively oral FXIa inhibitor in China: Safety, tolerability, pharmacokinetics and pharmacodynamics combined with aspirin, clopidogrel or ticagrelor.
Ma T, Dong Y, Huang L, Yang Y, et al · · 2022 · cited 9× · PMID 36339534 · DOI 10.3389/fphar.2022.1027627 -
Safety, tolerability, pharmacokinetics and pharmacodynamics of milvexian with aspirin and/or clopidogrel in healthy participants.
Perera V, Abelian G, Luettgen J, Aronson R, et al · · 2024 · cited 1× · PMID 39025971 · DOI 10.1038/s41598-024-67182-8
Verify or expand the search:
- PubMed search for NCT04945616
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04945616 (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: 1 July 2022
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/NCT04945616.
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