A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects

HS-10390-101

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.

2023-05-23

2024-02-16

2024-02-16

Recruiting

Early phase I

84

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}

2023-07-14