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

NCT03668509 | Unknown Phase 1

• 1 other identifier: SHR1459-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

SHR1459; Phase 1

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of single oral doses of SHR1459 determined by adverse events

  Frequency and severity of AEs and serious AEs

  within 4 days after single dose

Study Arms (3)

Cohort 1

EXPERIMENTAL

oral adminstration of SHR1459, dose 1

Drug: SHR1459

Cohort 2

EXPERIMENTAL

oral adminstration of SHR1459, dose 2

Drug: SHR1459

Cohort 3

EXPERIMENTAL

oral adminstration of SHR1459, dose 3

Drug: SHR1459

Interventions

SHR1459 DRUG

oral adminstration, single dose

Also known as: Placebo

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Xu qian, M.D. Ph.D

Shanghai, China

RECRUITING

Central Study Contacts

Hua Zhang, MD

CONTACT

+86-512-67780040; sdfyy8040@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 12, 2018
• Study Start: September 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

CN (1)