Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

NCT ID: NCT04219865

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2019-08-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Compound Edaravone

10 mL per vial (containing edaravone 10 mg and 2-aminoethanesulfonic acid 200 mg)

Group Type: ACTIVE_COMPARATOR

Group 1: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min

Group 2: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min

Group 3: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min

Group 4: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min

Group 5: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

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

Placebo

10 mL per vial

Group Type: PLACEBO_COMPARATOR

Group 1: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min

Group 2: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min

Group 3: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min

Group 4: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

Compound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min

Group 5: Compound Edaravone/Placebo Injection

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 18-65 years old (including upper and lower limits);

2. Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);

3. Understand and sign the informed consent voluntarily, and volunteer to participate in this research.

Exclusion Criteria

1. A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;

2. A comprehensive physical examination, neurological examination, laboratory examination, ECG examination, or cognitive assessment indicates that the subject has an abnormality that the researcher has determined to be clinically significant;

3. Have taken any drug within two weeks before the study administration, and the researcher believes that this situation may affect the evaluation results of this study;

4. There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;

5. Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);

6. A history of alcohol or drug abuse that the investigator believes may affect the evaluation results of this study within one year before the study administration;

7. Cannot quit smoking or drinking during the study period or the carbon monoxide breath test> 7 ppm during the screening period CO breath test, so if the subject's CO breath is> 7ppm, but the urine cotinine test is negative, it means that the CO breath test result may be false positive, the subject can be enrolled;

8. As a subject who has participated in any drug clinical trial within 3 months before the first administration of the study;

9. Those who donated blood or blood products ≥400 mL or 2 units within three months of the study;

10. Do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or vigorous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion, etc. during the 24 hours before and during the test;

11. Pregnant or lactating women, or those who tested positive for serum HCG before the test administration, or those who were unable or unwilling to take researcher-approved contraception during the study according to the researcher's instructions;

12. Subjects with poor compliance or unable to comply with the relevant provisions of the research protocol due to personal reasons, the investigator judges that the subjects are not suitable to participate in this clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Yoko Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

NJYK-CPEDRV-I

Identifier Type: -

Identifier Source: org_study_id