Psoriasis
Conditions
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.
Interventions
DRUGHS-10374 tablets
Single or multiple dosing of HS-10374 orally in a fasting state
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Vz/F | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) | Apparent volume of distribution |
| Cmax | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) | Maximum plasma concentration |
| Rac | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) | Accumulation ratio |
| 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 |
Countries
China
Outcome results
None listed