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

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

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: SHR1459


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>oral adminstration of SHR1459, dose 1 | Drug: SHR1459<br>* oral adminstration, single dose<br>* Other names: Placebo;|
| Experimental: Cohort 2<br>oral adminstration of SHR1459, dose 2 | Drug: SHR1459<br>* oral adminstration, single dose<br>* Other names: Placebo;|
| Experimental: Cohort 3<br>oral adminstration of SHR1459, dose 3 | Drug: SHR1459<br>* oral adminstration, single dose<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR1459, Phase 1