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Completed

NCT Number: NCT03769831

The PK/PD Study of SHR2285 Tablets in Healthy Subjects

Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, 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 and 50mmHg ≤DBP<90mmHg;
  • body mass index (BMI) between 18 to 28, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg
  • Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Exclusion criteria

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 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 trauma or surgery within 3 months prior to the screening;
  • Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;
  • Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
  • 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;
  • Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Treatment and study plan

SHR2285

Drug

Ascending dose oral adminstration

Placebo

Drug

Ascending dose oral adminstration

Primary outcomes

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

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

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of SHR2285

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

  2. Maximum observed serum concentration (Cmax) of SHR2285

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

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

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

  4. Time to elimination half-life (T1/2) of SHR2285

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

  5. Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285

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

  6. Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285

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

  7. Mean Residence Time(MRT) of SHR2285

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

  8. Change of APTT, PT, INR from baseline.

    Time frame: during Pre and Post-dose

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
May 24, 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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