The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects
Phase 1
Completed
- Conditions
- Thrombosis
- Interventions
- Drug: SHR2285 tabletDrug: Placebo
- Registration Number
- NCT04472819
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Inclusion Criteria
- Healthy subjects, aged 18-55 (including boundary);
- 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;
- Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
- Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
Exclusion Criteria
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > upper limit of normal (ULN) during screening/baseline.
- Serum creatinine> ULN during screening/baseline.
- Positive faecal occult blood
- 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, 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR2285 Part 1A SHR2285 tablet Participant received one of 7 dose levels of SHR2285 tablet as single-dose oral administration Placebo Part 1A Placebo Single ascending doses of placebo orally SHR2285 Part 1B SHR2285 tablet Participant received one dose of SHR2285 tablet as single-dose oral administration Placebo Part 1B Placebo Single doses of placebo orally SHR2285 Part 2 SHR2285 tablet Participant received one of 4 dose levels of SHR2285 tablet as multi-dose oral administration Placebo Part 2 Placebo Multiple ascending doses of placebo orally
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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 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 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 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 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 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 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
Trial Locations
- Locations (2)
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China