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

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

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.

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.

Inclusion Criteria:

1. 18~55 years old healthy subjects
2. BW ≥ 50 kg, BMI 18~28 kg/m²
3. Signed the informed consent from to participate voluntarily and to comply with the trial requirements

Exclusion Criteria:

1. History of clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic diseases
2. Clinically significant abnormality evidenced from detailed physical examination, 12-lead ECG, biochemistry, hematology, and routine urine analysis
3. Glomerular filtration rate (GFR) < 80 mL/min
4. Any medication within 2 weeks before the first administration in this study
5. History of clinically significant allergy and hypersensitivity
6. Hepatitis B or C, syphilis, or HIV infection on serological examination
7. History of alcoholic addiction or drug abuse within a year before this study
8. Failing of smoking and drunk cessation (Breath carbon monoxide test > 7 ppm) during this study
9. Participated in any drug trial within 3 months before this study
10. Donated blood or blood product ≥ 400 mL or 2 units within 3 months before this study
11. Dissented to avoid intake of tobacco, alcohol, or caffeine, and strenuous exercise or any behavior that would affect the ADME of YC-6
12. Pregnant or breast-feeding women
13. Other subject conditions unsuitable for enrollment in this study