The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SHR2285 Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses. |
Drug: SHR2285 tablet
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
Drug: Placebo
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
|
| Experimental: Placebo Participants received one of 3 dose levels of placebo administered as multiple oral doses. |
Drug: SHR2285 tablet
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
Drug: Placebo
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
|
Outcome Measures
Primary Outcome Measures
- Number of subjects with adverse events and serious adverse events. [Pre-dose to 7 days after multiple dose administration.]
Secondary Outcome Measures
- PK parameter will be evaluated. [Pre-dose to 3 days after single dose administration]
Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.
- Maximum observed serum concentration (Cmax) for single dose of SHR2285. [Pre-dose to 3 days after single dose administration]
- Time to maximum observed serum concentration (Tmax) for single dose of SHR2285. [Pre-dose to 3 days after single dose administration]
- 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.]
- Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285 [Pre-dose to 3 days after single dose administration.]
- Time to elimination half-life (T1/2) for single dose of SHR2285. [Pre-dose to 3 days after single dose administration]
- Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285. [Pre-dose to 2 days after multiple dose administration]
- Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285. [Pre-dose to 2 days after multiple dose administration]
- Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285. [Pre-dose to 2 days after multiple dose administration]
- Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285. [Pre-dose to 2 days after multiple dose administration.]
- Time to elimination half-life (T1/2) for multiple dose of SHR2285. [Pre-dose to 2 days after multiple dose administration]
- 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.]
- 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.]
- Accumulation ratio (Racc) for multiple dose of SHR2285. [Pre-dose to 2 days after multiple dose administration.]
- Percentage of fluctuation (PTF%) for multiple dose of SHR2285. [Pre-dose to 2 days after multiple dose administration.]
- PD parameter will be evaluated. [Pre-dose to 3 days after single dose administration.]
FXI activity; Change of APTT, PT, INR from baseline.
- PD parameter will be evaluated. [Pre-dose to 2 days after multiple dose administration.]
FXI activity; Change of APTT, PT, INR from baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
males or females, aged 18-45.
-
subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
-
body mass index (BMI) between 18 to 28.
-
Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
Exclusion Criteria:
-
males or females, aged 18-45.
-
subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
-
body mass index (BMI) between 18 to 28.
-
Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
Exclusion Criteria:
-
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline.
-
Serum creatinine> 1X ULN during screening/baseline.
-
Abnormal coagulation function.
-
A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
-
Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
-
Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejing Provincial People's Hospital | Hangzhou | Zhejiang | China | 310014 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR2285-102