The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2020-11-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04472819

Thrombosis

COMPLETED PHASE1

The PK/PD Study of SHR7280 Tablets in Healthy Subjects.

NCT04554043

Healthy Subjects

COMPLETED PHASE1

A PHASE I, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE DOSE ESCALATION STUDY TO INVESTIGATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SHR0534 IN HEALTHY VOLUNTEERS

NCT02749097

Healthy

COMPLETED PHASE1

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375

NCT05026008

Healthy Volunteers

COMPLETED PHASE1

A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers

NCT02750553

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SHR2285

Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.

Group Type EXPERIMENTAL

SHR2285 tablet

Intervention Type DRUG

Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.

Placebo

Intervention Type DRUG

Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.

Placebo

Participants received one of 3 dose levels of placebo administered as multiple oral doses.

Group Type EXPERIMENTAL

SHR2285 tablet

Intervention Type DRUG

Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.

Placebo

Intervention Type DRUG

Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR2285 tablet

Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.

Intervention Type DRUG

Placebo

Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. males or females, aged 18-45.
2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg; 50mmHg ≤DBP\<90mmHg and 50 ≤ HR \<110 beats / min.
3. body mass index (BMI) between 18 to 28.
4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria

1. males or females, aged 18-45.
2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg; 50mmHg ≤DBP\<90mmHg and 50 ≤ HR \<110 beats / min.
3. body mass index (BMI) between 18 to 28.
4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \> 1X ULN during screening/baseline.
2. Serum creatinine\> 1X ULN during screening/baseline.
3. Abnormal coagulation function.
4. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
5. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
6. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
7. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.

8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.

9.Female subjects who did not receive contraception at least 30 days before administration.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes