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

Guangzhou Cellprotek Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Ischemic Stroke

Treatments: Drug: YC-6; Drug: Vehicle

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03358901

YC-6-PI-M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

YC-6

Experimental group

Description:

6 volunteers in each level will be infused 100, 200, 400, or 600 mg of YC-6 over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day.

Treatment:

Drug: YC-6

Vehicle

Placebo Comparator group

Description:

2 volunteers in each level will be infused 2, 4, 8, or 12 g of vehicle over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day.

Treatment:

Drug: Vehicle