Thrombosis
Conditions
Brief summary
The study is a randomized, doubled-blinded, placebo-controlled, Phase I trials. The study is divided into two parts. The first part is a single-dose escalated study (SAD,part 1A ) and food effect study (SAD, part 1B ) in healthy subjects. The second part is a multi-dose escalated study (MAD) in healthy subjects.
Interventions
DRUGSHR2285 tablet
single dose or multi-dose
DRUGPlacebo
single dose or multi-dose
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects, aged 18-55 (including boundary); 2. Body mass index (BMI) between 18 to 28 kg/m2 (including boundary), male body weight ≥50 kg and \<90 kg , female body weight ≥45kg and \<90kg; 3. Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters. 4. Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
Exclusion criteria
1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \> upper limit of normal (ULN) during screening/baseline. 2. Serum creatinine\> ULN during screening/baseline. 3. Positive faecal occult blood 4. Abnormal coagulation function. 5. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs. 6. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening. 7. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration. 8. Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive. 9.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening. 10.Female subjects who did not receive contraception at least 30 days before administration and etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events and severity of adverse events. | Part 1: Pre-dose to day 7 after single dose administration and Part 2: Pre-dose to day 14after multiple dose administration |
| Maximum observed serum concentration (Cmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration |
| Time to maximum observed serum concentration (Tmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration |
| Time to elimination half-life (T1/2) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration |
| Area under the plasma concentration versus time curve (AUC0-last) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration |
Secondary
| Measure | Time frame |
|---|---|
| Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285. | Pre-dose to day 9 after multiple dose administration. |
| Accumulation ratio (Racc) for multiple dose of SHR2285. | Pre-dose to day 9 after multiple dose administration |
| Clotting factor XI (FXI) activity . | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Maximum observed serum concentration (Cmax) for single dose of SHR2285. | Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration |
| Change of prothrombin time (PT) from baseline. | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Change of international normalization ratio (INR) from baseline. | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Change of activated partial thromboplastin time (APTT) from baseline. | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Time to maximum observed serum concentration (Tmax) for single dose of SHR2285. | Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration |
| Time to elimination half-life (T1/2) for single dose of SHR2285. | Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration |
| Area under the plasma concentration versus time curve (AUC0-last) for single dose of SHR2285. | Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration |
| Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285. | Pre-dose to day 9 after multiple dose administration |
Countries
China
Outcome results
None listed