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The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10374 | Experimental | Single and multiple ascending doses of HS-10374 orally |
|
| Placebo | Placebo Comparator | Single and multiple ascending doses of HS-10374-matched placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10374 tablets | Drug | Single or multiple dosing of HS-10374 orally in a fasting state |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc. | Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) |
| Number of participants with abnormalities of vital signs | Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate. | Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) |
| Number of participants with abnormalities of physical examination | Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc. | Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) |
| Number of participants with abnormalities of electrocardiogram (ECG) parameters | ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval. | Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Tmax | Time to reach Cmax | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang, PhD | Huashan Hospital | Principal Investigator |
| Jinhua Xu, MD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| HS-10374-matched placebo tablets |
| Drug |
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state |
|
| AUC | Area under the plasma concentration-time curve | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| t½ | Terminal half-life | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| CL/F | Apparent clearance | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Vz/F | Apparent volume of distribution | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Rac | Accumulation ratio | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |