Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

Nanjing Yoko Biomedical

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Group 3: Compound Edaravone/Placebo Injection; Drug: Group 1: Compound Edaravone/Placebo Injection; Drug: Group 5: Compound Edaravone/Placebo Injection; Drug: Group 2: Compound Edaravone/Placebo Injection; Drug: Group 4: Compound Edaravone/Placebo Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04219865

NJYK-CPEDRV-I

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Compound Edaravone

Active Comparator group

Description:

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

Treatment:

Drug: Group 2: Compound Edaravone/Placebo Injection

Drug: Group 1: Compound Edaravone/Placebo Injection

Drug: Group 4: Compound Edaravone/Placebo Injection

Drug: Group 3: Compound Edaravone/Placebo Injection

Drug: Group 5: Compound Edaravone/Placebo Injection

Placebo

Placebo Comparator group

Description:

10 mL per vial

Treatment:

Drug: Group 2: Compound Edaravone/Placebo Injection

Drug: Group 1: Compound Edaravone/Placebo Injection

Drug: Group 4: Compound Edaravone/Placebo Injection

Drug: Group 3: Compound Edaravone/Placebo Injection

Drug: Group 5: Compound Edaravone/Placebo Injection