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

NCT ID: NCT03668509

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-03-01

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).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

oral adminstration of SHR1459, dose 1

Group Type: EXPERIMENTAL

SHR1459

Intervention Type: DRUG

oral adminstration, single dose

Cohort 2

oral adminstration of SHR1459, dose 2

Group Type: EXPERIMENTAL

SHR1459

Intervention Type: DRUG

oral adminstration, single dose

Cohort 3

oral adminstration of SHR1459, dose 3

Group Type: EXPERIMENTAL

SHR1459

Intervention Type: DRUG

oral adminstration, single dose

Interventions

SHR1459

oral adminstration, single dose

Intervention Type: DRUG

Other Intervention Names

Placebo

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xu qian, M.D. Ph.D

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua Zhang, MD

Role: CONTACT

sdfyy8040@126.com

+86-512-67780040

Facility Contacts

Qian Xu, Ph.D

Role: primary

xuqian@hrglobe.cn

+86-18721043271

Other Identifiers

SHR1459-101

Identifier Type: -

Identifier Source: org_study_id