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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03668509
• Other study ID #: SHR1459-101
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Hua Zhang, MD
• Phone: +86-512-67780040
• Email: sdfyy8040[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SHR1459
oral adminstration, single dose

Locations

Country	Name	City	State
China	Xu qian, M.D. Ph.D	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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