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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03358901
• Other study ID #: YC-6-PI-M
• Status: Recruiting
• Phase: Phase 1
• First received: December 16, 2016
• Last updated: December 4, 2017
• Start date: December 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2017
• Source: Guangzhou Cellprotek Pharmaceutical Co., Ltd.
• Contact: Yan Sun, BM
• Phone: 86(10)69158355
• Email: cprc[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• YC-6

• Vehicle

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Cellprotek Pharmaceutical Co., Ltd.	Xiuhe Medical Technique Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)	Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment.	Day 0 to Day 11
Secondary	Plasma Concentration of YC-6	Concentration of YC-6 in plasma of every subject will be measured during day 0 to day 8.	Day 0 to Day 8