Anterior ST-segment elevation myocardial infarction
Conditions
Sponsors
Beijing Anzhen Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for this trial: 1. Fully understand the purpose, nature, methods of the trial and possible adverse reactions, voluntarily serve as a subject, and sign the informed consent form; 2. Healthy subjects aged 18 to 50 years old (including the boundary value, based on the time of signing the informed consent form), regardless of gender; 3. The body mass index (BMI) is within the range of 19.0 to 26.0 kg/m^2(including the critical value), with a weight of no less than 50.0 kg for men and no less than 45.0 kg for women. Female subjects with fertility must agree to use effective contraceptive measures from the screening period to three months after receiving the investigational drug. His male partner who is fertile must also agree to use effective contraceptive measures during this period. 5. Male subjects with fertility must agree to use effective contraceptive measures from the screening period to three months after receiving the investigational drug, and have no plans to have children or donate sperm. During this period, her fertile female partner must also agree to use effective contraceptive measures.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the following criteria: 1.Individuals with known allergy to therapeutic protein drugs or food or who may be allergic to the test drug or any component of the investigational drug, based on the investigator’s judgment. 2.Individuals with a history of cardiovascular disease. 3.Individuals with a history of acute or chronic bronchospasm, including treated or untreated asthma, and chronic obstructive pulmonary disease (COPD). 4.Individuals with a history of autoimmune disease. 5.Individuals with a history of malignant tumors. 6.Individuals with clinically significant abnormalities on physical examination, vital signs examination, electrocardiogram or laboratory tests, as judged by the clinician. 7.Individuals with a history of drug abuse within the past 5 years, the presence of drug abuse within 3 months before the study, or a positive drug abuse screening result. 8.Individuals who have smoked within 3 months before screening (consuming ? 5 cigarettes per day) or habitual use of nicotine containing products. 9.Individuals who have consumed more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% of alcohol content or 150 mL of wine) within 3 months prior to screening, or who consume alcohol-containing products within 48 hours before dosing, or who have a positive alcohol breath test result. 10.Individuals who have received monoclonal antibody or biologic therapy within 3 months prior to receiving the investigational drug. 11.Individuals who have received medications that may affect the immune system (e.g., immunosuppressants, cytokines and cytokine inducers,) within 3 months prior to receiving the investigational drug. 12.Individuals who have received anticoagulant or antiplatelet medications within 28 days prior to receiving the investigational drug. 13.Individuals who have received any vaccine within 28 days prior to receiving the investigational drug, or who plan to receive a vaccine during the trial period. 14.Individuals who have suffered from clinically significant major diseases or undergone major surgical procedures within 28 days prior to receiving the investigational drug, or who anticipate requiring major surgery during the trial period. 15.Individuals who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 14 days prior to receiving the investigational drug or within the 5 half-lives of the drug (whichever is longer). 16.Individuals whose screening viral serology tests are positive for human immunodeficiency virus antigen/antibodies (HIV-Ag/Ab), hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV-Ab), or positive for antibodies to Treponema pallidum (TP-Ab). 17.Individuals who have difficulty in venous blood collection or have a history of needle and blood fainting. 18.Women who have positive result in pregnancy test or are breastfeeding at Screening or D-1. 19.Individuals who have participated in other drug clinical studies and received other clinical trial drugs within 3 months prior to receiving the investigational drug. 20.Individuals who have history of blood donation or massive blood loss (? 400 mL) within 3 months prior to screening. 21.Any other circumstance that, in the judgement of the investigator, may affect the ability of the subject to provide informed consent or to follow the trial protocol, or where the subject's participation i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints: Adverse events (AEs), Serious adverse events (SAEs), physical examinations, vital signs (blood pressure, pulse and temperature), 12-lead electrocardiogram (ECG), and laboratory tests (hematology, chemistry, urinalysis, and coagulation).; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK endpoints;PD endpoints;Immunogenicity endpoints; | — |
Countries
China
Contacts
Public ContactYang Lin, Shan Jing
Beijing Anzhen Hospital Capital Medical University
Outcome results
None listed