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

NCT04229433 | Completed Phase 1

• 1 other identifier: SHR2285-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombus

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events and serious adverse events.

  Pre-dose to 7 days after multiple dose administration.

Secondary Outcomes (17)

• PK parameter will be evaluated.

  Pre-dose to 3 days after single dose administration

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

  Pre-dose to 3 days after single dose administration

• Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.

  Pre-dose to 3 days after single dose administration

• Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.

  Pre-dose to 3 days after single dose administration.

• Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285

  Pre-dose to 3 days after single dose administration.

Study Arms (2)

SHR2285

EXPERIMENTAL

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

Drug: SHR2285 tablet; Drug: Placebo

Placebo

EXPERIMENTAL

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

Drug: SHR2285 tablet; Drug: Placebo

Interventions

SHR2285 tablet DRUG

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

Placebo; SHR2285

Placebo DRUG

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

Placebo; SHR2285

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• males or females, aged 18-45.
• subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg; 50mmHg ≤DBP\<90mmHg and 50 ≤ HR \<110 beats / min.
• body mass index (BMI) between 18 to 28.
• Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \> 1X ULN during screening/baseline.
• Serum creatinine\> 1X ULN during screening/baseline.
• Abnormal coagulation function.
• A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
• Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
• Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
• Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.
• months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.
• Female subjects who did not receive contraception at least 30 days before administration.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhejing Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 18, 2020
• Study Start: August 11, 2020
• Primary Completion: November 8, 2020
• Study Completion: November 8, 2020
• Last Updated: May 25, 2021

Record last verified: 2020-01

Locations

CN (1)