Trials / Completed
CompletedNCT03769831
The PK/PD Study of SHR2285 Tablets in Healthy Subjects
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR2285 | Ascending dose oral adminstration |
| DRUG | Placebo | Ascending dose oral adminstration |
Timeline
- Start date
- 2019-02-25
- Primary completion
- 2019-07-22
- Completion
- 2019-07-22
- First posted
- 2018-12-10
- Last updated
- 2021-05-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03769831. Inclusion in this directory is not an endorsement.