A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults

Exclusion Criteria

• •Any clinically significant abnormal finding at physical examination at screening.
• •Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) types 1 and 2 antibodies at screening.
• •The subject has one or more of the following laboratory abnormalities at screening:
• •1. Hemoglobin ≤10.5 g/dL
• •2. Platelet count ≤99999 /mm3
• •3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 × upper limit of normal \[ULN\] or higher
• •4. Lipase 1.5 × ULN or higher
• •5. Serum creatinine 1.5 × ULN or higher
• •6. Any other clinically significant laboratory abnormality as judged by the Investigator
• •Positive pregnancy test or lactating female subject.
• •Positive urine drug screen, urine cotinine test, or alcohol breath test on Day -1.
• •Known allergic reactions to FB825 or other related drugs, or to any excipient in the formulation.
• •Clinically significant ECG abnormalities or vital signs abnormalities at screening.
• •History of risk factors for torsade de pointes syndrome.
• •History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening.
• •History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
• •The subject lives in, has recently (within 6 months of screening) lived in or traveled to, or is planning to travel to, an area where parasitic infections are endemic. In cases of uncertainty, it can be judged by the Investigator prior to enrolling the subject in the study.
• •The subject has clinically relevant, currently active or underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, immunological, endocrine, or infectious disease. This includes subjects with asthma, eosinophilic disease of any origin, IgE abnormalities, or urticaria of all types.
• •The subject has a clinically significant history, as determined by the Investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillins, or a drug allergy witnessed in a previous study with experimental drugs.
• •The subject has any history of a previous anaphylactic reaction.
• •The subject has used a concomitant medication, including over-the-counter (OTC) products, herbal medications, dietary supplements, and vitamin supplements within 14 days before Day -1.
• •The subject has received any immunoglobulin products or blood products within 6 months of Day -1 or has any previous participation in a clinical research study involving the administration of FB825.
• •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 half-lives, whichever is longer) prior to Day -1, administration of a biological product in the context of a clinical research study within 90 days prior to Day -1, or concomitant participation in an investigational study involving no drug or device administration.
• •Donation of plasma within 2 months prior to dosing or donation or loss of 500 mL or more of whole blood within 2 months prior to dosing.
• •Subject has the presence of tattoos, sunburn, or other skin disturbances on injection/infusion site which may interfere with a medical assessment of the injection/infusion site both prior to and following dosing.
• •The subject is a member of the site study team.
• •The subject has any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.