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

Hansoh Pharma

Status and phase

Completed

Phase 1

Conditions

Psoriasis

Treatments

Drug: HS-10374-matched placebo tablets

Drug: HS-10374 tablets

Study type

Interventional

Funder types

Industry

Identifiers

HS-10374-101

Details and patient eligibility

About

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

Enrollment

84 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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 of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing
Have signed the informed consent form approved by the IRB

Exclusion criteria

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
Have a history of or current allergic disease
Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
Pregnant or breastfeeding female subjects
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