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This study adopted a single-center, randomized, double-blind, placebo-controlled, dose-escalation design and was divided into three parts: single-dose dose-escalation (SAD) 、 multiple-dose dose-escalation (MAD)、drug-drug interaction(DDI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental |
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| Treatment group 2 | Experimental |
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| Treatment group 3 | Experimental |
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| Treatment group 4 | Experimental |
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| Treatment group 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-8829;Placebo | Drug | Subject will receive HRS-8829 at dose level 1. Subject will receive placebo at dose level 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | From ICF signing date to Day8 after single administration | |
| The incidence and severity of adverse events | From ICF signing date to Day15 after multiple administrations | |
| The Incidence and severity of adverse events | from the date of ICF signing to the 21st day after DDI administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of HRS-8829 and its metabolite in plasma (Cmax) | 0 hour to 48 hour after single administration | |
| Area under the serum concentration time curve (AUC) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China |
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| HRS-8829;Placebo | Drug | Subject will receive HRS-8829 at dose level 2. Subject will receive placebo at dose level 2. |
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| HRS-8829;Placebo | Drug | Subject will receive HRS-8829 at dose level 3. Subject will receive placebo at dose level 3. |
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| HRS-8829;Placebo | Drug | Subject will receive HRS-8829 at dose level 4. Subject will receive placebo at dose level 4. |
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| HRS-8829;Edaravone injection | Drug | Subject will receive HRS-8829 at dose level 2. Subject will receive edaravone injection at dose level 5. |
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| Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Half-life (T1/2) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Clearance (CL) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Volume of distribution (Vz) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Cumulative amount excreted (Ae0-t) of HRS-8829 and its metabolite in urine | 0 hour to 48 hour after single administration |
| Cumulative excretion fraction (Fe0-t) of HRS-8829 and its metabolite in urine | 0 hour to 48 hour after single administration |
| Renal clearance (CLr) of HRS-8829 and its metabolite in urine | 0 hour to 48 hour after single administration |
| Maximum observed concentration at steady-state of HRS-8829 and its metabolite in plasma (Cmax) | Day1 to Day15 after multiple administrations |
| Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolite in plasma | Day1 to Day15 after multiple administrations |
| Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolite in plasma | Day1 to Day15 after multiple administrations |
| Half-life (T1/2) of HRS-8829 and its metabolite in plasma | Day1 to Day15 after multiple administrations |
| Clearance (CL) of HRS-8829 and its metabolite in plasma | Day1 to Day15 after multiple administrations |
| Volume of distribution (Vz) of HRS-8829 and its metabolite in plasm | Day1 to Day15 after multiple administrations |
| Maximum observed concentration at steady-state of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day 16 after DDI study single-dose, plasma administrations |
| Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Half-life (T1/2) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Clearance (CL) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Volume of distribution (Vz) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study multiple-dose, plasma administrations |
| Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study multiple-dose, plasma administrations |
| Half-life (T1/2) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study multiple-dose, plasma administrations |
| Volume of distribution (Vz) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study multiple-dose, plasma administrations |