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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: SHR2285 tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04472819

SHR2285-104

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 6 patient groups, including a placebo group

SHR2285 Part 1A

Experimental group

Description:

Participant received one of 7 dose levels of SHR2285 tablet as single-dose oral administration

Treatment:

Drug: SHR2285 tablet

Placebo Part 1A

Placebo Comparator group

Description:

Single ascending doses of placebo orally

Treatment:

Drug: Placebo

SHR2285 Part 1B

Experimental group

Description:

Participant received one dose of SHR2285 tablet as single-dose oral administration

Treatment:

Drug: SHR2285 tablet

Placebo Part 1B

Placebo Comparator group

Description:

Single doses of placebo orally

Treatment:

Drug: Placebo

SHR2285 Part 2

Experimental group

Description:

Participant received one of 4 dose levels of SHR2285 tablet as multi-dose oral administration

Treatment:

Drug: SHR2285 tablet

Placebo Part 2

Placebo Comparator group

Description:

Multiple ascending doses of placebo orally

Treatment:

Drug: Placebo