Healthy Volunteers
Conditions
Keywords
SHR1459, Phase 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.
Detailed description
The study originally planned to enroll 3 cohorts of 10 subjects each (N=30).
Interventions
DRUGSHR1459
oral adminstration, single dose
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactHua Zhang, MD
Outcome results
None listed