Status:
COMPLETED
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Psoriasis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06033742
Start Date
November 13 2021
End Date
March 24 2023
Last Update
September 13 2023
Active Locations (1)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040