Clinical trial NCT03668509: Safety, Tolerability and PK/PD of SHR1459 in Healthy Volunteers
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR1459, in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: SHR1459
Phase 1
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: Safety and tolerability of single oral doses of SHR1459 determined by adverse events
timeFrame: within 4 days after single dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xu qian, M.D. Ph.D
Study officials:
References: