๐ฌIn 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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ 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 โฅ5 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