Clinical trial NCT03358901: Safety and Pharmacokinetics of Multiple Dose of YC-6 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ischemic Stroke
Lead sponsor: Guangzhou Cellprotek Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xiuhe Medical Technique Co.,Ltd.
First posted: 2017-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Day 0 to Day 11
Secondary outcomes:
measure: Plasma Concentration of YC-6
timeFrame: Day 0 to Day 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Bei Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: