Thrombus
Conditions
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.
Interventions
DRUGSHR2285 tablet
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
DRUGPlacebo
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events and serious adverse events. | Pre-dose to 7 days after multiple dose administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. | — |
| 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 single dose of SHR2285. | Pre-dose to 3 days after single 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. |
| Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285 | Pre-dose to 3 days after single dose administration. | — |
Countries
China
Outcome results
None listed