Safety and Pharmacokinetics of Multiple Dose of YC-6 in Healthy Subjects

Study Overview
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Brief Summary
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The study is designed to determine the safety, tolerability, and pharmacokinetics in healthy subjects with multiple intravenous administration of the neuroprotectant YC-6 compared to placebo.

Detailed Description
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tPA administration within 3-4.5 hours after stroke onset has been the only approved therapy and thus no more than 7% of acute ischemic stroke (AIS) victims worldwide benefited from tPA. A neuroprotectant, YC-6, showed therapeutic effects in preclinical animal models of AIS, indicating its potential as alternative or combined treatment against human AIS. This randomized, double-blind, placebo-controlled clinical trial is to explore safety and tolerability in healthy Chinese adult volunteers with dose-escalating intravenous infusion of YC-6 for 7 consecutive days. 6 subjects for YC-6 and 2 for placebo will be allocated in each level. Blood and urine samples of each subject will be used in determination of pharmacokinetic properties of the investigational drug.

Official Title
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A Phase I, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Administration of YC-6 in Healthy Chinese Adult Subjects

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: YC-6
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 55 years old healthy subjects BW ≥ 50 kg, BMI 18 28 kg/m² Signed the informed consent from to participate voluntarily and to comply with the trial requirements Exclusion Criteria: History of clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic diseases Clinically significant abnormality evidenced from detailed physical examination, 12-lead ECG, biochemistry, hematology, and routine urine analysis Glomerular filtration rate (GFR) < 80 mL/min Any medication within 2 weeks before the first administration in this study History of clinically significant allergy and hypersensitivity Hepatitis B or C, syphilis, or HIV infection on serological examination History of alcoholic addiction or drug abuse within a year before this study Failing of smoking and drunk cessation (Breath carbon monoxide test > 7 ppm) during this study Participated in any drug trial within 3 months before this study Donated blood or blood product ≥ 400 mL or 2 units within 3 months before this study Dissented to avoid intake of tobacco, alcohol, or caffeine, and strenuous exercise or any behavior that would affect the ADME of YC-6 Pregnant or breast-feeding women Other subject conditions unsuitable for enrollment in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YC-6<br>6 volunteers in each level will be infused 100, 200, 400, or 600 mg of YC-6 over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day. | Drug: YC-6<br> <br> |
| Placebo Comparator: Vehicle<br>2 volunteers in each level will be infused 2, 4, 8, or 12 g of vehicle over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day. | Drug: Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs) | Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment. | Day 0 to Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of YC-6 | Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8. | Day 0 to Day 8 |