A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects
- Conditions
- Psoriasis
- Interventions
- Drug: HS-10374 tabletsDrug: HS-10374-matched placebo tablets
- Registration Number
- NCT06033742
- Lead Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HS-10374 HS-10374 tablets Single and multiple ascending doses of HS-10374 orally Placebo HS-10374-matched placebo tablets Single and multiple ascending doses of HS-10374-matched placebo orally
- Primary Outcome Measures
Name Time Method Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) Number of participants with clinical laboratory abnormalities 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 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 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 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 Outcome Measures
Name Time Method Cmax Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) Maximum plasma concentration
Tmax Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) Time to reach Cmax
AUC Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) Area under the plasma concentration-time curve
t½ Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) Terminal half-life
CL/F Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) Apparent clearance
Vz/F Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) Apparent volume of distribution
Rac Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) Accumulation ratio
Trial Locations
- Locations (1)
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China