A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects

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

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

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