Ischemic Stroke
Conditions
Interventions
Experimental group:Single dose: ALT001 will be administered intravenously once on Day 1.
Multiple doses: ALT001 will be administered intravenously once daily from Day 1 for 14 consecutive days.
Placebo group:Single dose: Placebo will be administered intravenously once on Day 1.
Multiple doses: Placebo will be administered intravenously once daily from Day 1 for 14 consecutive days.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for enrollment in this trial: 1. Healthy male or female subjects aged 18 to 45 years (inclusive of the upper and lower limits), with age determined by the date of signing the informed consent form; 2. Body Mass Index (BMI) ranging from 18.5 to 27.9 kg/m^2 (inclusive of the upper and lower limits); male subjects must have a body weight of no less than 50 kg and female subjects no less than 45 kg; 3. In good general health as assessed by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function) and viral serology results, with all test findings being either normal or showing clinically insignificant abnormalities; 4. Female subjects must be non-pregnant and non-lactating; all subjects (male and female) must agree to use medically accepted effective contraceptive measures from the screening period until 6 months after the last administration of the investigational product; 5. Subjects must voluntarily agree to and be capable of participating in the study, sign the informed consent form, and commit to completing all study-related procedures and visits in accordance with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this trial: 1. Having an allergic diathesis (allergic to multiple drugs and foods), a history of severe hypersensitivity/anaphylactic reactions, or being judged by the investigator to be at risk of allergy to the investigational product or any of its components (e.g., a prior history of allergy to protein-based drugs); 2. Complicated with other severe and/or uncontrolled diseases of vital organs or unstable systemic diseases during the screening period, including but not limited to uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), severe congestive heart failure, uncontrolled hypertension, uncontrollable active infection, severe hepatic, renal or other metabolic diseases, and severe gastrointestinal diseases; 3. Having clinically significant abnormal white blood cell or neutrophil counts during the screening period as determined by the investigator; 4. Having abnormal liver function during the screening period: total bilirubin >1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) >1.5×ULN, alanine aminotransferase (ALT) >1.5×ULN; 5. Having an estimated glomerular filtration rate (eGFR) 450 ms (per Fridericia’s correction), or a family history of congenital long QT syndrome; 7. Having a history of bleeding tendency or confirmed coagulation factor abnormalities (e.g., congenital coagulation factor deficiency); 8. Having abnormal vital signs after rest during the screening period, including systolic blood pressure 139 mmHg, diastolic blood pressure 89 mmHg, and pulse rate 100 beats/min; 9. Having undergone major surgery within 6 months before screening, or planning to undergo surgery during the trial; 10. Having an alcohol consumption of more than 14 alcohol units per week within 6 months before screening (1 alcohol unit = 360 mL beer, 45 mL spirits [40% alcohol by volume], or 150 mL wine), having consumed alcohol-containing products within 72 hours before drug administration, or having a positive breath alcohol test result (>0 mg/100mL); 11. Having a daily cigarette consumption of more than 5 cigarettes or habitual use of nicotine-containing products (including but not limited to e-cigarettes, pipe tobacco, cigars, chewing tobacco, nicotine patches, lozenges or gum, Varenicline, Bupropion) within 3 months before screening, or having a positive nicotine screening result; 12. Having donated blood or suffered blood loss >400 mL within 3 months before screening, donated blood or suffered blood loss >200 mL within 4 weeks before screening, or planning to donate blood during the trial; 13. Having received systemic immunosuppressants (e.g., corticosteroids, Methotrexate, Azathioprine, Cyclosporine, etc.) within 4 weeks before screening; 14. Having taken any prescription drugs, over-the-counter (OTC) drugs, Chinese herbal medicines or dietary supplements within 2 weeks before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (AEs) and serious adverse events (SAEs), including incidence, type, severity, duration, relationship to the study drug, dose relationship, etc.; proportion of subjects who discontinued due to drug toxicity.;During the dose-escalation observation period: incidence of Significant Intolerance Events (SIE) in each dose cohort; exploration of the Maximum Tolerated Dose (MTD); and evaluation of the Recommended Dose (RD) for subsequent studies.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cytokines (IFN-?, IL-10, IL-13, IL-1ß, IL-4, IL-5, IL-6, GRO-a, TNF-a, IL-2) and immune function parameters (IgG, IgM, IgA, CD3+CD4+, CD3+CD8+, CD3+CD4+/CD3+CD8+ ratio, CD28+, CD16+) before and after dosing.; | — |
Countries
China
Contacts
Public ContactYilong Wang
Capital Medical University Affiliated Beijing Tiantan Hospital
Outcome results
None listed