The PK/PD Study of SHR2285 Tablets in Healthy Subjects

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769831
• Other study ID #: SHR2285-101
• Status: Completed
• Phase: Phase 1
• Start date: February 25, 2019
• Est. completion date: July 22, 2019

Study information

• Verified date: December 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. males or females, aged 18-45

2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg =SBP<140mmHg and 50mmHg =DBP<90mmHg;

3. body mass index (BMI) between 18 to 28, and a total body weight: male =50.0 kg and <90.0 kg; female =45.0 kg and <90.0 kg

4. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Exclusion Criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1X ULN during screening/baseline;

2. Abnormal coagulation function;

3. A clinical history of coagulation dysfunction;subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.

4. Subjects with severe trauma or surgery within 3 months prior to the screening;

5. Known blood donation within 30 days pre-dose; donating=400 ml of blood 3 months pre-dose;

6. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;

7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;

8. Pregnant or Serum ß-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• SHR2285
Ascending dose oral adminstration
• Placebo
Ascending dose oral adminstration

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events and serious adverse events		Pre-dose to 7 days after dose administration
Secondary	Area under the plasma concentration versus time curve (AUC) of SHR2285		Pre-dose to 2 days after dose administration
Secondary	Maximum observed serum concentration (Cmax) of SHR2285		Pre-dose to 2 days after dose administration
Secondary	Time to maximum observed serum concentration (Tmax) of SHR2285		Pre-dose to 2 days after dose administration
Secondary	Time to elimination half-life (T1/2) of SHR2285		Pre-dose to 2 days after dose administration
Secondary	Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285		Pre-dose to 2 days after dose administration
Secondary	Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285		Pre-dose to 2 days after dose administration
Secondary	Mean Residence Time(MRT) of SHR2285		Pre-dose to 2 days after dose administration
Secondary	Change of APTT, PT, INR from baseline.		during Pre and Post-dose