A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants

Exclusion Criteria

• •Underlying physical or psychological medical condition to comply with the protocol or complete the study per protocol
• •Genetic disorder with severe and abnormal bilirubin metabolism
• •Blood or plasma donation or significant blood loss prior to the first administration of IP
• •Viral or bacterial infection prior to the first administration of IP
• •Poor venous access
• •Significant scarring or tattoos at the planned site of IP administration
• •History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
• •History or active cardiovascular, respiratory, kidney, endocrine, blood, digestive, central nervous, urinary and/or musculoskeletal disease
• •History of malignancy prior to Screening
• •Abnormal ECG findings
• •History or presence of a condition associated with significant immunosuppression
• •History of life-threatening infection
• •Infections requiring parenteral antibiotics
• •Vaccination prior to the first administration of IP
• •Exposure to any significantly immune suppressing drug
• •Abnormal vital signs findings
• •Abnormal laboratory findings
• •Positive results for viral testing at Screening
• •Positive result at Screening and Day -1 for toxicology screening panel
• •History of substance abuse or dependency or history of recreational intravenous (IV) drug use
• •Excess of regular alcohol consumption
• •Use of any IP or investigational medical device within 30 days prior to Screening
• •Unable to adhere to the prohibited therapies
• •Unwilling to adhere to the dietary restrictions
• •Unwilling to refrain from strenuous exercise