Status:
UNKNOWN
Safety and Pharmacokinetics of Multiple Dose of YC-6 in Healthy Subjects
Lead Sponsor:
Guangzhou Cellprotek Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Xiuhe Medical Technique Co.,Ltd.
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed 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 neuroprotect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03358901
Start Date
December 1 2016
End Date
January 1 2018
Last Update
December 6 2017
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China