Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

Phase 1

Completed

• Conditions: Pharmacokinetics

• Registration Number: NCT04219865
• Lead Sponsor: Nanjing Yoko Biomedical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-05
• Primary Completion: 2019-08-16
• Study Completion: 2019-08-16
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection	24 hours
Cmax of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection	24 hours
Cmax of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection	7 Days
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection	7 Days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events of compound edaravone injection	7 Days

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China