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The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10390 | Experimental | Single or multiple dosing of HS-10390 in a fastingstate |
|
| Placebo | Experimental | Single or multiple dosing of placebo in a fastingstate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10390 tablet | Drug | Oral administration of specified dose of HS-10390 |
| |
| 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 28 (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) | |
| Time to reach Cmax (Tmax) | 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Bicheng Liu | Contact | 18001580838 | liubc64@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D005923 | Glomerulosclerosis, Focal Segmental |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Placebo tablet |
| Drug |
Oral administration of matching dose ofplacebo |
|
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) |
| Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Half time (t½) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Apparent clearance (CL/F) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Apparent volume of distribution (Vz/F) | Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD) |
| Accumulation ratio(Rac) | Day 14 up to Day 19 (MAD) |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |