A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects

HS-10374-101

The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.

2021-11-13

2023-03-24

2023-03-24

Completed

Early phase I

84

Inclusion Criteria: 1. Healthy male or female subjects between the ages of 18-45 years 2. Have no reproductive potential; or agree to use a highly effective method of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing 3. Have signed the informed consent form approved by the IRB Exclusion Criteria: 1. Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, viral hepatitis, AIDS and syphilis 2. Have a history of or current allergic disease 3. Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse 4. Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine 5. Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests 6. Pregnant or breastfeeding female subjects 7. Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period

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

2023-09-13