HS-10390 tablet: Oral administration of specified dose of HS-10390
Placebo tablet: Oral administration of matching dose ofplacebo
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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 ≥5 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
Primary outcome measure(s)
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation — Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
Trial sites (1)
Facility
City
Region
Status
Zhongda Hospital, Affiliated to Southeast University
Nanjing
Jiangsu
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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