The PK/PD Study of SHR2285 Tablets in Healthy Subjects

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03769831
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 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
• Actual Study Start Date: Feb 25, 2019
• Actual Primary Completion Date: Jul 22, 2019
• Actual Study Completion Date: Jul 22, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of subjects with adverse events and serious adverse events [Pre-dose to 7 days after dose administration]

Secondary Outcome Measures

1. Area under the plasma concentration versus time curve (AUC) of SHR2285 [Pre-dose to 2 days after dose administration]

2. Maximum observed serum concentration (Cmax) of SHR2285 [Pre-dose to 2 days after dose administration]

3. Time to maximum observed serum concentration (Tmax) of SHR2285 [Pre-dose to 2 days after dose administration]

4. Time to elimination half-life (T1/2) of SHR2285 [Pre-dose to 2 days after dose administration]

5. Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285 [Pre-dose to 2 days after dose administration]

6. Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285 [Pre-dose to 2 days after dose administration]

7. Mean Residence Time(MRT) of SHR2285 [Pre-dose to 2 days after dose administration]

8. Change of APTT, PT, INR from baseline. [during Pre and Post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: 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:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin

1X ULN during screening/baseline;

1. Abnormal coagulation function;

2. A clinical history of coagulation dysfunction；subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.

3. Subjects with severe trauma or surgery within 3 months prior to the screening；

4. Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;

5. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;

6. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;

7. Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100032

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03769831
• Other Study ID Numbers: SHR2285-101
• First Posted: Dec 10, 2018
• Last Update Posted: May 24, 2021
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombosis

Study Results

No Results Posted as of May 24, 2021