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
Overview
- Phase
- Phase 1
- Intervention
- HS-10374 tablets
- Conditions
- Psoriasis
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
HS-10374
Single and multiple ascending doses of HS-10374 orally
Intervention: HS-10374 tablets
Placebo
Single and multiple ascending doses of HS-10374-matched placebo orally
Intervention: HS-10374-matched placebo tablets
Outcomes
Primary Outcomes
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with clinical laboratory abnormalities
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Number of participants with abnormalities of vital signs
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Number of participants with abnormalities of physical examination
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Time Frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Secondary Outcomes
- Cmax(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Tmax(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- AUC(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- t½(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- CL/F(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Vz/F(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Rac(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))