Acute Ischemia Stroke
Conditions
Brief summary
This study adopted a single-center, randomized, double-blind, placebo-controlled, dose-escalation design and was divided into three parts: single-dose dose-escalation (SAD) 、 multiple-dose dose-escalation (MAD)、drug-drug interaction（DDI）
Interventions
DRUGHRS-8829;Placebo
Subject will receive HRS-8829 at dose level 1. Subject will receive placebo at dose level 1.
DRUGHRS-8829;Edaravone injection
Subject will receive HRS-8829 at dose level 2. Subject will receive edaravone injection at dose level 5.
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female subjects aged 18 to 55 years old 2. The weight of female subjects was ≥45 kg, that of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-28.0 kg/m2 3. The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator. 4. Voluntarily participate in this clinical trial
Exclusion criteria
1. Have any history of allergies 2. Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc 3. The electrocardiogram at lead 12 was abnormal and was judged by the researcher as unsuitable to participate in this study 4. Those who test positive for any one of hepatitis B surface antigen, hepatitis C antibody, syphilis specific antibody or human immunodeficiency virus antigen-antibody during the screening period 5. Those whose screening period examination results are judged by the research doctor as abnormal and of clinical significance 6. Those who have used any drugs that inhibit or induce liver enzymes within one month before administration 7. Those who have used or are currently using any medication within two weeks prior to administration 8. Those who have received a vaccine within one month prior to screening (except for the influenza vaccine) or plan to receive a vaccine during the trial period 9. Those who have undergone major surgical operations within the six months prior to screening 10. Blood donation or loss of more than 400 mL within 3 months prior to screening 11. Participate in the clinical trial of the drug as a subject and take the trial drug 12. Consumed more than 14 units of alcohol per week on average within the 3 months prior to screening 13. Those who smoked more than 5 cigarettes or an equivalent amount of tobacco per day 14. Those who consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages daily 15. Consume special food within 48 hours before administration 16. Those with a history of drug abuse 17. Those who cannot tolerate venipuncture 18. Those who have special dietary requirements 19. The researchers believe that the subjects have any other factors that make them unsuitable for participating in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | From ICF signing date to Day8 after single administration |
| The Incidence and severity of adverse events | from the date of ICF signing to the 21st day after DDI administration |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed concentration of HRS-8829 and its metabolite in plasma (Cmax) | 0 hour to 48 hour after single administration |
| Area under the serum concentration time curve (AUC) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Half-life (T1/2) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Clearance (CL) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Volume of distribution (Vz) of HRS-8829 and its metabolite in plasma | 0 hour to 48 hour after single administration |
| Cumulative amount excreted (Ae0-t) of HRS-8829 and its metabolite in urine | 0 hour to 48 hour after single administration |
| Cumulative excretion fraction (Fe0-t) of HRS-8829 and its metabolite in urine | 0 hour to 48 hour after single administration |
| Renal clearance (CLr) of HRS-8829 and its metabolite in urine | 0 hour to 48 hour after single administration |
| Maximum observed concentration at steady-state of HRS-8829 and its metabolite in plasma (Cmax) | Day1 to Day15 after multiple administrations |
| Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolite in plasma | Day1 to Day15 after multiple administrations |
| Volume of distribution (Vz) of HRS-8829 and its metabolite in plasm | Day1 to Day15 after multiple administrations |
| Maximum observed concentration at steady-state of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day 16 after DDI study single-dose, plasma administrations |
| Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Half-life (T1/2) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Clearance (CL) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
| Volume of distribution (Vz) of HRS-8829 and its metabolites M01 and edaravone | Day1 to Day16 after DDI study single-dose, plasma administrations |
Countries
China
Outcome results
None listed