The PK/PD Study of SHR2285 Tablets in Healthy Subjects

NCT03769831 | Completed Phase 1

• 1 other identifier: SHR2285-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events and serious adverse events

  Pre-dose to 7 days after dose administration

Secondary Outcomes (8)

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

  Pre-dose to 2 days after dose administration

• Maximum observed serum concentration (Cmax) of SHR2285

  Pre-dose to 2 days after dose administration

• Time to maximum observed serum concentration (Tmax) of SHR2285

  Pre-dose to 2 days after dose administration

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

  Pre-dose to 2 days after dose administration

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

  Pre-dose to 2 days after dose administration

Study Arms (2)

SHR2285

EXPERIMENTAL

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

Drug: SHR2285

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

SHR2285 DRUG

Ascending dose oral adminstration

SHR2285

Placebo DRUG

Ascending dose oral adminstration

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (1)

• 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.

  PMID: 35222036 DERIVED

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: February 25, 2019
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: May 24, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)