Safety, Tolerability and PK/PD of SHR1459 in Healthy Volunteers

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: SHR1459

• Registration Number: NCT03668509
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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).

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-01
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12
• Primary Completion: 2019-01-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	SHR1459	oral adminstration of SHR1459, dose 1
Cohort 2	SHR1459	oral adminstration of SHR1459, dose 2
Cohort 3	SHR1459	oral adminstration of SHR1459, dose 3

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single oral doses of SHR1459 determined by adverse events	within 4 days after single dose	Frequency and severity of AEs and serious AEs

Trial Locations

Locations (1)

Xu qian, M.D. Ph.D; 🇨🇳 Shanghai, China