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

Thrombosis Clinical Trial

Official title:

A Phase I, Randomized, Double -Blinded, Placebo-Controlled, Single and Multiple Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472819
• Other study ID #: SHR2285-104
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• SHR2285 tablet
single dose or multi-dose
• Placebo
single dose or multi-dose

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Steady-state peak concentration (Cmax,ss) for multiple dose of SHR2285.		Pre-dose to day 9 after multiple dose administration
Secondary	Steady state valley concentration (Ctrough,ss) for multiple dose of SHR2285.		Pre-dose to day 9 after multiple dose administration.
Secondary	Accumulation ratio (Racc) for multiple dose of SHR2285.		Pre-dose to day 9 after multiple dose administration
Secondary	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
Secondary	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
Secondary	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
Secondary	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