The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Jiangsu HengRui Medicine Co., Ltd.104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

104

Conditions

Thrombosis

Interventions

SHR2285 tabletDRUG

single dose or multi-dose

PlaceboDRUG

single dose or multi-dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Peking University First Hospital

Beijing, Beijing Municipality, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

Number of subjects with adverse events and severity of adverse events.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration

Secondary Outcomes

Maximum observed serum concentration (Cmax) for single dose of SHR2285.

Time frame: 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 maximum observed serum concentration (Tmax) for single dose of SHR2285.

Time frame: Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration

Data from ClinicalTrials.gov

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