stroke
Conditions
Interventions
40 mg (3 cases test drug, 1 case placebo):On the day of administration (Day 1) in the morning, LY02003 or placebo will be given by intravenous infusion, administered once, with a single infusion time
80mg (8 cases test drug, 2 cases placebo):On the day of administration (Day 1) in the morning, LY02003 or placebo will be given by intravenous infusion, administered once, with a single infusion time
160mg (8 cases test drug, 2 cases placebo):On the day of administration (Day 1) in the morning, LY02003 or placebo will be given by intravenous infusion, administered once, with a single infusion time
320mg (8 cases test drug, 2 cases placebo):On the day of administration (Day 1) in the morning, LY02003 or placebo will be given by intravenous infusion, administered once, with a single infusion time
480mg (8 cases test drug, 2 cases placebo):On the day of administration (Day 1) in the morning, LY02003 or placebo will be given by intravenous infusion, administered once, with a single infusion time
640mg (8 cases test drug, 2 cases placebo):On the day of administration (Day 1) in the morning, LY02003 or placebo will be given by intravenous infusion, administered once, with a single infusion time
Sponsors
Xiangya Third Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and provide a signed informed consent form with the date indicated; 2. Be aged 18 to 45 years (inclusive) at the screening visit, and be a healthy male or female; 3. Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg. Body mass index (BMI) must be within the range of 19.0–26.0 kg/m^2 (inclusive); 4. For female participants, the following conditions must be met: a. No reproductive potential, including participants who have undergone surgical sterilization (documented tubal ligation, hysterectomy, or bilateral salpingectomy), as well as participants who are postmenopausal or have had continuous amenorrhea for more than 12 months at the screening visit; or b. If of reproductive potential, must not be pregnant or breastfeeding, and must agree to use non-drug contraception for 14 days prior to dosing, during the study, and for 1 month following dosing, with a negative human chorionic gonadotropin (hCG) test at the screening visit and on Day -1 (D-1); male participants and female partners with reproductive potential must agree to use appropriate contraception for 14 days prior to dosing, during the study, and for 1 month after the last dose. Participants must not donate sperm or eggs during this period; 5. Willing to comply with study visit schedules, study treatments, laboratory tests, and other study-related procedures and requirements as specified in the research protocol.
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational drug or its excipients, or a history of severe allergies (including any food or drug allergies); 2. History of significant diseases or conditions affecting the central nervous system, respiratory system, cardiovascular system, digestive system, hematologic system, endocrine system, musculoskeletal system, urinary system, or tumors, or any existing acute illness, or any other disease or condition that the investigator deems may affect the study or pose an unacceptable risk to the participant; 3. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis treponemal antibody (TP-Ab); 4. Resting systolic blood pressure (SBP) =140 or 100 or <50 beats per minute (bpm); 6. Clinically significant 12-lead ECG abnormalities, or QTcF interval (Fridericia correction) =450 ms for males, or =460 ms for females; 7. Screening or baseline serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than the upper limit of normal (ULN); 8. Estimated glomerular filtration rate (GFR) <90 mL/min/1.73 m² based on the CKD-EPI creatinine formula; 9. History of drug abuse (e.g., morphine, methamphetamine, ketamine, MDMA, THC derivatives, etc.), or positive drug screening test; 10. Heavy alcohol consumption in the past 12 months (more than 21 standard units per week, with 1 standard unit containing 14g of alcohol, e.g., 360 mL of 5% beer, 45 mL of 40% spirits, 120 mL of 12% wine), or positive breath alcohol test, or inability to comply with the restriction of no alcohol intake from 14 days prior to dosing until 36 hours after the last dose while collecting PK samples; 11. Average smoking of more than 5 cigarettes per day within 3 months prior to screening, or inability to comply with the restriction of no nicotine product use from 14 days prior to dosing until the last study visit; 12. Consumption of foods or beverages that induce or inhibit liver metabolism enzymes (e.g., grapefruit) within 7 days prior to first study drug administration; unwillingness or inability to ensure no intake of foods or beverages containing caffeine or xanthines, or producing them after metabolism (e.g., coffee, tea, chocolate), from 48 hours prior to the first study drug administration until completion of the last pharmacokinetic blood sampling; 13. Receipt of any vaccines within 30 days prior to screening, or planning to receive any vaccines during the study; 14. From 14 days before administration (if the five half-lives of the used drug exceed 14 days, then based on five half-lives) to the last visit, it is not permissible to use any drugs, including prescription and over-the-counter drugs (excluding locally applied eye/nasal drops and creams without systemic exposure risk), vitamins (excluding routine vitamins), health supplements, and Chinese herbal medicines; 15. Received any investigational drug treatment or participated in any drug/device clinical trial within 3 months before administration; 16. Underwent major surgery within 30 days before administration or plans to undergo major surgery during this study; 17. Donated blood or had a blood loss of =400 mL, or received a blood transfusion within 3 months before screening; 18. Judged by the investigator as having other severe systemic diseases, laboratory abnormalities, or other reasons making them unsuitable to participate in this stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Heart rate;Physical examination;QT interval corrected for heart rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactYang Guoping
Xiangya Third Hospital, Central South University
Outcome results
None listed