A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR1459, in Healthy Volunteers

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country30 target enrollmentSeptember 1, 2018

ConditionsHealthy Volunteers

InterventionsSHR1459

DrugsSHR1459

Overview

Phase: Phase 1
Intervention: SHR1459
Conditions: Healthy Volunteers
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: Safety and tolerability of single oral doses of SHR1459 determined by adverse events
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This was a phase I, single-center, double-blind, randomized, placebo-controlled study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of the investigational medicinal product in healthy volunteers.

Detailed Description

The study originally planned to enroll 3 cohorts of 10 subjects each (N=30).

Registry

clinicaltrials.gov

Start Date

September 1, 2018

End Date

March 1, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, of any ethnic origin, age ≥18 and ≤45 years of age;
•BMI ≥19 and ≤26 kg/m2; Men's weight≥ 50kg, Women's weight ≥ 45kg;
•Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator; all clinical tests of blood, urine, ECG and X-ray are within the normal range or show no clinically relevant deviations as judged by the Investigator;
•There is no birth plan during the trial and within 1 month after the completion of the trial, and the subject must agree to use one of the effective contraceptive methods;
•Able to comprehend and abide by the study restrictions, and willing to sign an Informed Consent Form (ICF)

Exclusion Criteria

•Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
•Has a history of malignant or lymphoproliferative disorders;
•Has a history of bleeding tendency or coagulopathy (eg, uncontrolled autoimmune hemolysis and thrombocytopenic purpura, severe hematopoietic defects, gastrointestinal bleeding), or recent bleeding events;
•Has a history of stroke or intracranial hemorrhage within 6 months prior to screening;
•Has any surgery performed within 3 months prior to screening, or during the study period and within 1 month after the end of the study;
•Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
•Has diseases affecting drug absorption, distribution, metabolism, and excretion (eg, gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc);
•Has active tuberculosis by clinical symptoms, signs, laboratory tests, or X-ray examinations;
•Has infections including acute and chronic infections, local infections such as sepsis, abscesses, and opportunistic infections that were clinically significant by the investigator in the 3 months prior to screening;
•Has blood donation and donated ≥400 mL within 3 months before screening ; or received any blood product infusion; or received plasma exchange or blood cell clearance treatment;