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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Peking Union Medical College Hospital
Beijing, China
RECRUITINGNumber 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.
Time frame: Day 0 to Day 11
Plasma Concentration of YC-6
Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8.
Time frame: Day 0 to Day 8
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