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This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Y-2 sublingual tablet dose group 1 | Experimental |
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| Y-2 sublingual tablet dose Group 2 | Experimental |
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| Y-2 sublingual tablet dose Group 3 | Experimental |
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| Y-2 sublingual tablet dose Group 4 | Experimental |
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| Y-2 sublingual tablet dose Group 5 | Experimental |
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| Placebo | Placebo Comparator | Certain subjects in group 1 and group 2 will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y-2 Sublingual Tablet | Drug | Subjects will receive one Y-2 sublingual tablet sublingually once daily for Day1 and Day 19 and twice daily for Day 6 to Day 18. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events(Part 1) | To evaluate the safety and tolerability following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1. | Until follow-up(Day26)or early termination |
| Maximum concentration(Cmax)in Part 2 healthy adult subjects | To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2. | Day1,Day2, Day6,Day7,Day11,Day12 |
| Time for Cmax (Tmax) in Part 2 healthy adult subjects | To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2. | Day1,Day2, Day6,Day7,Day11,Day12 |
| Area under the curve (AUC) in Part 2 healthy adult subjects | To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2. | Day1,Day2, Day6,Day7,Day11,Day12 |
| Terminal elimination half-life(t1/2) in Part 2 healthy adult subjects | To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2. | Day1,Day2, Day6,Day7,Day11,Day12 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration(Cmax)in Part 1 healthy adult subjects | To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1. | Day1,Day2,Day6 and Day18 to Day20 |
| Time for Cmax (Tmax) in Part 1 healthy adult subjects |
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Inclusion Criteria:
Inclusion Criteria
Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 and weight ≥ 50kg at screening.
A condition of general good health, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following condition applies:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Han, MD | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International Los Angeles Early Phase Clinical Unit | Glendale | California | 91206 | United States |
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| Y-2 Sublingual Tablet | Drug | Subjects will receive two Y-2 sublingual tablets sublingually once daily for Day1 and Day 19 and twice daily for Day 6 to Day 18. |
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| Y-2 Sublingual Tablet | Drug | Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition A, Day 6 with condition B and Day 11 with condition C. |
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| Y-2 Sublingual Tablet | Drug | Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition B, Day 6 with condition C and Day 11 with condition A. |
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| Y-2 Sublingual Tablet | Drug | Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition C, Day 6 with condition A and Day 11 with condition B. |
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| Placebo | Drug | Placebo, sublingually, single and multiple ascending dosing in group 1 and 2 subjects. |
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To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1. |
| Day1,Day2,Day6 and Day18 to Day20 |
| Area under the curve (AUC) in Part 1 healthy adult subjects | To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1. | Day1,Day2,Day6 and Day18 to Day20 |
| Terminal elimination half-lifet(1/2 )in Part 1 healthy adult subjects | To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1. | Day1,Day2,Day6 and Day18 to Day20 |
| Adverse Events(Part 2) | To evaluate the safety following different single administration conditions of Y-2 sublingual tablet in healthy adult subjects in part 2. | Until follow-up(Day18)or early termination |