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A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

RecruitingPhase 1Ages 18 Years - 45 YearsAllHansoh BioMedical R&D Company
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In plain words

What the trial is, and whether it could suit you

The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Healthy male or female subjects between the ages of 18-45 years * Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing * Have signed the informed consent form approved by the IRB Exclusion Criteria: * History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator * Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis * Have a history of or current allergic disease * Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse * Smokers smoked โ‰ฅ5 cigarettes per day within past 3 months or have a positive test resultfor nicotine * Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests * Pregnant or breastfeeding female subjects
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What it tests

  • HS-10390 tablet
  • Placebo tablet
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Where

1 site
Zhongda Hospital, Affiliated to Southeast University
Nanjing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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