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

Ischemic Stroke Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03358901
Study type Interventional
Source Guangzhou Cellprotek Pharmaceutical Co., Ltd.
Contact Yan Sun, BM
Phone 86(10)69158355
Email cprc@pumch.cn
Status Recruiting
Phase Phase 1
Start date December 2016
Completion date January 2018
View Details
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