A Study to Assess the Safety, Tolerability and Effects of Compound Edaravone Injection (Edaravone + Borneol).

INTERVENTION: This is a Single Ascending Dose study. Each subject only receives one dose level once during the study. The cohort is completed and reviewed by a safety review panel before dosing for the next cohort commences. There are 6 cohorts comprised of 8 subjects. The study drug is administered via intravenous injection over 30 minutes and the dosing regieme for each cohort is listed below: Cohort 1: 5 mg Edaravone + 1.25 mg Borneol compound or placebo Cohort 2: 15 mg Edaravone + 3.75 mg Borneol compound or placebo Cohort 3: 30 mg Edaravone + 7.5 mg Borneol compound or placebo Cohort 4: 60 mg Edaravone + 15 mg Borneol compound or placebo Cohort 5: 90 mg Edaravone + 22.5 mg Borneol compound or placebo Cohort 6: 120 mg Edaravone + 30 mg Borneol compound or placebo CONDITION: This study involves recruiting healthy subjects to trial a drug intended to treat Ischaemic Stroke. PRIMARY OUTCOME: The primary objective is to evaluate the safety and tolerability of rising single doses of the combination of Compound Edaravone when administered intravenously in healthy male and female adult subjects. ; ; Safety will be assessed by measuring: vital signs (blood pressure, pulse rate, temperature, and oxygen saturation), ECG (heart tracing), safety blood tests, physical examination findings, and adverse events. Vital signs and adverse events will be assessed daily at each visit. ECG readings will be assessed at screening, Day ‐1, Day 1, Day 2, and Day 3. Blood tests will be assessed at screening, Day ‐1, Day 2, Day 3, and at follow‐up. Brief physical examinations will be done on Day ‐1 and a standard physical examination will be done at screening and at the final follow‐up visit. A total of 91.5 mL of blood will be collected from each subject for analysis of safety laboratory parameters. SECONDARY OUTCOME: The secondary objective is to characterize the single‐dose pharmacokinetics (PK) of Edaravone and Borneol in healthy male and female adult subjects. INCLUSION CRITERIA: 1. Healthy adult male and female subjects, 18‐55 years of age, inclusive, at the time of signing the informed consent; 2. Body weight greater than or equal to 50 kg and body mass index (BMI) within the range 18‐30 kg/m2, inclusive, at screening; 3. Medically healthy subjects with clinically insignificant screening and check‐in results (medical histories, 12‐lead ECG, physical exam, and laboratory tests); 4. Women of childbearing potential with a negative urine pregnancy test at screening and check‐in who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control during the study; 5. Male subjects must agree to use barrier contraception (condom with spermicide) in addition to having their female partner (if of child‐bearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subderm