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

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

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