A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
IgA Nephropathy, Focal Segmental Glomerulosclerosis
About this trial
This is an interventional treatment trial for IgA Nephropathy focused on measuring HS-10390, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
Eligibility Criteria
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
Sites / Locations
- Zhongda Hospital, Affiliated to Southeast UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
HS-10390
Placebo
Single or multiple dosing of HS-10390 in a fastingstate
Single or multiple dosing of placebo in a fastingstate