NCT04945616

To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects

Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Aspirin、clopidogrel、placebo or SHR2285	groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ；
DRUG	Aspirin、clopidogrel、placebo or SHR2285	groupB： Aspirin + clopidogrel + placebo or SHR2285 (dose 2)
DRUG	Aspirin、ticagrelor、placebo or SHR2285	groupC： Aspirin + ticagrelor + placebo or SHR2285

Timeline

• Start date: 2021-07-13
• Primary completion: 2021-10-19
• Completion: 2022-06-15
• First posted: 2021-06-30
• Last updated: 2022-07-01

Locations

1 site across 1 country: China