Clinical Research Directory

Inclusion Criteria: * Subjects must meet the following criteria to be eligible for study entry: 1. Healthy male or female subjects age ≥ 18 and ≤ 55 years. 2. Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m². 3. Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant. 4. Signed Informed consent form for participation in the study. Exclusion Criteria: * Subjects who meet any of the following criteria will be excluded from study entry 1. Hypersensitivity to the Investigational Medicinal Product (IMP) or any of its components, to biological agents, or prior history of severe drug hypersensitivity reactions. 2. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunologic, dermatologic, psychiatric or neurological disease, or other significant clinical findings within 3 months before screening. 3. History of malignancy within 5 years prior to screening, with the exception of patients with a negligible risk of metastases or death and/or treated with expected curative outcome. 4. Family history of premature Coronary Heart Disease. 5. Pregnant or Breastfeeding subject, women with positive pregnancy test (hCG). 6. Unlikely to comply with the clinical study protocol.