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Completed

NCT Number: NCT04229433

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhejing Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Exclusion criteria

  • 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.

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.

Treatment and study plan

SHR2285 tablet

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Pre-dose to 7 days after multiple dose administration.

Secondary outcomes

  1. PK parameter will be evaluated.

    Time frame: Pre-dose to 3 days after single dose administration

    Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.

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

    Time frame: Pre-dose to 3 days after single dose administration

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

    Time frame: Pre-dose to 3 days after single dose administration

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

    Time frame: Pre-dose to 3 days after single dose administration.

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

    Time frame: Pre-dose to 3 days after single dose administration.

  6. Time to elimination half-life (T1/2) for single dose of SHR2285.

    Time frame: Pre-dose to 3 days after single dose administration

  7. Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration

  8. Steady-state peak concentration (Cmax,ss) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration

  9. Steady state valley concentration (Ctrough,ss) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration

  10. Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration.

  11. Time to elimination half-life (T1/2) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration

  12. Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration.

  13. Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration.

  14. Accumulation ratio (Racc) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration.

  15. Percentage of fluctuation (PTF%) for multiple dose of SHR2285.

    Time frame: Pre-dose to 2 days after multiple dose administration.

  16. PD parameter will be evaluated.

    Time frame: Pre-dose to 3 days after single dose administration.

    FXI activity; Change of APTT, PT, INR from baseline.

  17. PD parameter will be evaluated.

    Time frame: Pre-dose to 2 days after multiple dose administration.

    FXI activity; Change of APTT, PT, INR from baseline.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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