Acute Ischemic Stroke
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.
Interventions
DRUGHRS-4029
HRS-4029
DRUGPlacebo
Placebo
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. Age between 18 to 55 years. 2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive). 3. Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period. 4. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Exclusion criteria
1. Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded. 2. Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator . 3. Subjects with positive tests for infectious diseases. 4. Female who are pregnant or breastfeeding. 5. Unable to tolerate venipunctures or have a history of fainting needles and blood. 6. Historic abuse of alcoholic beverages 7. Smoke ≥5 cigarettes per day within 3 months prior to the study 8. History of drug abuse. 9. Other reasons that the investigator consider it inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | From ICF signing date to Day15 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum concentration time curve (AUC) of HRS-4029 | 0 hour to 48 hour after administration |
| Time to maximum observed concentration (Tmax) of HRS-4029 | 0 hour to 48 hour after administration |
| Half-life (T1/2) of HRS-4029 | 0 hour to 48 hour after administration |
| Maximum observed concentration of HRS-4029 (Cmax) | 0 hour to 48 hour after administration |
| Volume of distribution (Vz) of HRS-4029 | 0 hour to 48 hour after administration |
| Number of subjects who developed HRS-4029 antidrug antibodies (ADA) | Baseline to Day15 |
| Clearance (CL) of HRS-4029 | 0 hour to 48 hour after administration |
Countries
China
Contacts
Primary ContactYuanyuan Huang
Outcome results
None listed