Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer

Exclusion Criteria

• •Common
• •1. Subjects who have received or treated with following medications within the specified timeframe prior to Screening (Visit 1) or who are expected to receive them during the study period:
• •* Within 1 month: Hyaluronidase, Chemotherapeutic agent, non-steroidal anti-inflammatory drugs (NSAIDs; e.g.: Aspirin, Aceclofenac, etc.), penicillins antibiotics (e.g.: Amoxicillin, Ampicillin, etc.), cephalosporins antibiotics (e.g.: Cefaclor, Cefadroxil, Cefixime, etc.), sulfonamides antibiotics (e.g.: Sulfadiazine, Sulfamethoxazole, etc.), quinolones antibiotics (e.g.: Ciprofloxacin, Levofloxacin, etc.), Glucocorticosteroid, Immunosuppressive agent
• •* Within 14 days: Antihistamine (e.g.: Chlorpheniramine, Hydroxyzine, Ketotifen, etc.)
• •2. Subjects who have prior history of clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, hematology/neoplasm, cardiovascular system, mental (mood disorder, obsessive-compulsive disorder), gastrointestinal disorders or surgical history
• •3. Subjects with acute fever \> 37.5℃ within 7 days from the expected IP administration or showing symptoms suspecting acute diseases within 14 days from the expected IP administration
• •4. Subjects who do not have normal blood pressure\*
• •\*Range of normal blood pressure is defined as systolic and diastolic blood \<120/80 mmHg in accordance with 2018 Korean Society of Hypertension Guidelines for the Management of Hypertension24) (however, Pre-hypertension (≥ 130/80) is excluded that may occur in normotension).
• •5. Subjects who persistently drink more than the weekly recommended alcohol units\* 14 g of alcohol content per unit is applied, which corresponds to 1 can (small bottle) of beer (5%), 350 mL of draft beer (5%), 1 cup (300 mL) of makgeoli, 1 glass (150 mL) of wine (12%), 1/4 bottle (90 mL) of soju (20%), and 1 shot (45 mL) of liquor (40%). Moderate amount of alcohol by age and gender is provided below:23) Age Recommended unit per week Adults (≥ 19 and \< 65 years) Male: 8 units/week Female: 4 units/week Elderly (≥ 65 years) Male: 4 units/week Female: 2 units/week
• •6. Subjects of usual smoker (exceeding 10 cigarettes per day)
• •7. Subjects who have a past history of autoimmune diseases (e.g.: rheumatoid arthritis, etc.) or active immune diseases that may affect the immune system \[e.g.: flu, cancer, Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV) etc.\], diabetes mellitus, heart diseases, asthma, sinusitis, chronic urticaria, dermographism, or any skin conditions that may affect post-IP administration assessments (e.g.: Dermatitis, dermatomycosis and other skin diseases or tattoo)
• •8. Subjects with known allergic reactions or hypersensitivity to bee sting or other common allergens or known contraindications to hyaluronidase, thimerosal (disinfectants) and EDTA
• •9. Subjects with hypersensitivity to the IP or its ingredients or a history of anaphylaxis
• •10. Past history of drug abuse
• •11. Subjects who have participated in other clinical trials within 6 months prior to the expected IP administration
• •12. Others determined ineligible for the study participation in the opinion of investigator
• •Part II-A
• •13. Subjects who have been treated with a drug-metabolizing enzyme inducers and inhibitors\*25), 26) within 30 days prior to the IP administration
• •\* Example: Phenytoin, Carbamazepine, Barbiturates, Rifampicin, Griseofulvin, Cimetidine, Disulfiram, Erythromycin, Ketoconazole, Fluconazole, Itraconazole, Valproic acid, Isoniazid, Ciprofloxacin, Omeprazole, Clarithromycin, Quinidine, Sulfonamides, etc.
• •14. Subjects who have significant bleeding or blood loss within 60 days prior to Screening (Visit 1)
• •15. Subjects who have donated whole blood within 60 days or donated blood by apheresis within 14 days or received transfusion within 14 days prior to Screening (Visit 1)
• •16. Subjects who have consumed grapefruit juice28) within 7 days prior to Screening (Visit 1)