Clinical trial NCT04229433: The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombus
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with adverse events and serious adverse events.
timeFrame: Pre-dose to 7 days after multiple dose administration.
Secondary outcomes:
measure: PK parameter will be evaluated.
timeFrame: Pre-dose to 3 days after single dose administration
measure: Maximum observed serum concentration (Cmax) for single dose of SHR2285.
timeFrame: Pre-dose to 3 days after single dose administration
measure: Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.
timeFrame: Pre-dose to 3 days after single dose administration
measure: Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.
timeFrame: Pre-dose to 3 days after single dose administration.
measure: Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285
timeFrame: Pre-dose to 3 days after single dose administration.
measure: Time to elimination half-life (T1/2) for single dose of SHR2285.
timeFrame: Pre-dose to 3 days after single dose administration
measure: Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration
measure: Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration
measure: Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration
measure: Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration.
measure: Time to elimination half-life (T1/2) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration
measure: Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration.
measure: Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration.
measure: Accumulation ratio (Racc) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration.
measure: Percentage of fluctuation (PTF%) for multiple dose of SHR2285.
timeFrame: Pre-dose to 2 days after multiple dose administration.
measure: PD parameter will be evaluated.
timeFrame: Pre-dose to 3 days after single dose administration.
measure: PD parameter will be evaluated.
timeFrame: Pre-dose to 2 days after multiple dose administration.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejing Provincial People's Hospital
state: Zhejiang
Study officials:
References: