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Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

NCT04219865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nanjing Yoko Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2019-08-16
Completion
2019-08-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04219865 on ClinicalTrials.gov