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

Phase 1

• Conditions: Ischemic Stroke
• Interventions: Drug: YC-6; Drug: Vehicle

• Registration Number: NCT03358901
• Lead Sponsor: Guangzhou Cellprotek Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2017-11-26
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study First Posted: 2017-12-02
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YC-6	YC-6	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.
Vehicle	Vehicle	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)	Day 0 to Day 11	Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of YC-6	Day 0 to Day 8	Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China