NCT04219865

Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Nanjing Yoko Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Group 1: Compound Edaravone/Placebo Injection	Compound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min
DRUG	Group 2: Compound Edaravone/Placebo Injection	Compound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min
DRUG	Group 3: Compound Edaravone/Placebo Injection	Compound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min
DRUG	Group 4: Compound Edaravone/Placebo Injection	Compound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min
DRUG	Group 5: Compound Edaravone/Placebo Injection	Maximum tolerated dose of drug / placebo for a single intravenous infusion for 30 minutes three times a day at an interval of 8 h until the last dose on the morning of Day 3, after which the sequential test drug 30 mg-600 mg / placebo will be administered daily from Day 3 night Intravenous infusion, 30 minutes at 12-hour intervals until morning on Day 7

Timeline

• Start date: 2019-06-05
• Primary completion: 2019-08-16
• Completion: 2019-08-16
• First posted: 2020-01-07
• Last updated: 2021-03-22

Locations

1 site across 1 country: China