The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

Thrombus Clinical Trial

Official title:

A Phase I, Randomized, Single -Blind, Placebo-Controlled, Multiple 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: NCT04229433
• Other study ID #: SHR2285-102
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2020
• Est. completion date: November 8, 2020

Study information

• Verified date: January 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 8, 2020
• Est. primary completion date: November 8, 2020
• 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; 50mmHg =DBP<90mmHg and 50 = HR <110 beats / min.

3. body mass index (BMI) between 18 to 28.

4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria:

1. males or females, aged 18-45.

2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg =SBP<140mmHg; 50mmHg =DBP<90mmHg and 50 = HR <110 beats / min.

3. body mass index (BMI) between 18 to 28.

4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria:

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

2. Serum creatinine> 1X ULN during screening/baseline.

3. Abnormal coagulation function.

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

5. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.

6. Blood donation or blood loss within 1 month=200 mLor=400 mL within 3 months before administration.

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

8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.

9.Female subjects who did not receive contraception at least 30 days before administration.

Related Conditions & MeSH terms

• Thrombosis
• Thrombus

Intervention

Drug:
• SHR2285 tablet
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
• Placebo
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.

Locations

Country	Name	City	State
China	Zhejing Provincial People's Hospital	Hangzhou	Zhejiang

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 multiple dose administration.
Secondary	PK parameter will be evaluated.	Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.	Pre-dose to 3 days after single dose administration
Secondary	Maximum observed serum concentration (Cmax) for single dose of SHR2285.		Pre-dose to 3 days after single dose administration
Secondary	Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.		Pre-dose to 3 days after single dose administration
Secondary	Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.		Pre-dose to 3 days after single dose administration.
Secondary	Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285		Pre-dose to 3 days after single dose administration.
Secondary	Time to elimination half-life (T1/2) for single dose of SHR2285.		Pre-dose to 3 days after single dose administration
Secondary	Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration
Secondary	Steady-state peak concentration (Cmax,ss) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration
Secondary	Steady state valley concentration (Ctrough,ss) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration
Secondary	Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration.
Secondary	Time to elimination half-life (T1/2) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration
Secondary	Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration.
Secondary	Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration.
Secondary	Accumulation ratio (Racc) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration.
Secondary	Percentage of fluctuation (PTF%) for multiple dose of SHR2285.		Pre-dose to 2 days after multiple dose administration.
Secondary	PD parameter will be evaluated.	FXI activity; Change of APTT, PT, INR from baseline.	Pre-dose to 3 days after single dose administration.
Secondary	PD parameter will be evaluated.	FXI activity; Change of APTT, PT, INR from baseline.	Pre-dose to 2 days after multiple dose administration.