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

NCT ID: NCT04472819

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2021-05-31

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.

Conditions

Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SHR2285 Part 1A

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

Group Type: EXPERIMENTAL

SHR2285 tablet

Intervention Type: DRUG

single dose or multi-dose

Placebo Part 1A

Single ascending doses of placebo orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single dose or multi-dose

SHR2285 Part 1B

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

Group Type: EXPERIMENTAL

SHR2285 tablet

Intervention Type: DRUG

single dose or multi-dose

Placebo Part 1B

Single doses of placebo orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single dose or multi-dose

SHR2285 Part 2

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

Group Type: EXPERIMENTAL

SHR2285 tablet

Intervention Type: DRUG

single dose or multi-dose

Placebo Part 2

Multiple ascending doses of placebo orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single dose or multi-dose

Interventions

SHR2285 tablet

single dose or multi-dose

Intervention Type: DRUG

Placebo

single dose or multi-dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

References

Xu J, Zhao N, Huang J, Li J, Zhao X, Xiang Q, Yang S, Dong Y, Wang H, Li Y, Yang G, Cui Y. The Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, an Oral Small Molecule Factor XIa Inhibitor, in Healthy Chinese Volunteers. Clin Drug Investig. 2023 Jun;43(6):435-445. doi: 10.1007/s40261-023-01281-8. Epub 2023 Jun 16.

Reference Type: DERIVED

PMID: 37326942 (View on PubMed)

Other Identifiers

SHR2285-104

Identifier Type: -

Identifier Source: org_study_id