Overview

Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

Status:
Completed
Trial end date:
2019-08-16
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Nanjing Yoko Biomedical Co., Ltd.
Treatments:
Edaravone
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.