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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

Completed Phase 1 Last updated 1 July 2022
What this trial tests

Phase 1 trial testing Aspirin、clopidogrel、placebo or SHR2285 in Thrombosis in 52 participants. Completed in 15 June 2022.

Timeline
13 July 2021
Primary endpoint
19 October 2021
15 June 2022

Quick facts

Lead sponsorJiangsu HengRui Medicine Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment52
Start date13 July 2021
Primary completion19 October 2021
Estimated completion15 June 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other recruiting trials for Thrombosis

Currently open trials in the same condition.

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing