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The PK/PD Study of SHR2285 Tablets in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03769831
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: SHR2285 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official 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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: SHR2285
Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.
Drug: SHR2285
Ascending dose oral adminstration

Experimental: Placebo
Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo.
Drug: Placebo
Ascending dose oral adminstration




Primary Outcome Measures :
  1. Number of subjects with adverse events and serious adverse events [ Time Frame: Pre-dose to 7 days after dose administration ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. males or females, aged 18-45
  2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg and 50mmHg ≤DBP<90mmHg;
  3. 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
  4. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Exclusion Criteria:

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1X ULN during screening/baseline;
  2. Abnormal coagulation function;
  3. A clinical history of coagulation dysfunction;subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
  4. Subjects with severe trauma or surgery within 3 months prior to the screening;
  5. Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;
  6. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
  7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;
  8. Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769831


Contacts
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Contact: Chen, Ph.D +86-010-69158355 chenrui04@126.com

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03769831     History of Changes
Other Study ID Numbers: SHR2285-101
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases