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CompletedNCT03769831Updated May 24, 2021

The PK/PD Study of SHR2285 Tablets in Healthy Subjects

A Phase 1 interventional study of SHR2285 and Placebo in Thrombosis, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-24.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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Conditions studied

  • Thrombosis

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 239 are open to participants now.

This study's enrollment of 28 is below the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    SHR2285

    Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.

    Drug: SHR2285

  • Experimental
    Placebo

    Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo.

    Drug: Placebo

Interventions

  • DrugSHR2285

    Ascending dose oral adminstration

  • DrugPlacebo

    Ascending dose oral adminstration

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What researchers measure

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

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Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100032, China
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References and documents

Publications

  • Chen R, Guan X, Hu P, Dong Y, Zhu Y, Zhang T, Zou J, Zhang S. First-In-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, a Small-Molecule Factor XIa Inhibitor in Healthy Subjects. Front Pharmacol. 2022 Feb 10;13:821363. doi: 10.3389/fphar.2022.821363. eCollection 2022. PubMed 35222036 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03769831
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Dec 10, 2018
Start date
Feb 25, 2019
Primary completion
Jul 22, 2019
Completion
Jul 22, 2019
Last update
May 24, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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