A Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of BITS7201A in Healthy Volunteers and Participants With Mild Atopic Asthma

Exclusion Criteria

• •History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
• •History of hematologic or immunosuppressive disorders
• •History of severe depression or suicidal ideation
• •History of inflammatory bowel disease
• •History of anaphylaxis, hypersensitivity, or significant drug allergies
• •History or presence of an abnormal ECG, which is clinically significant
• •History of a positive tuberculin skin test in participants who are Bacille Calmette-Guérin (BCG) vaccine naïve or history of a positive interferon-gamma release assay in participants who have received the BCG vaccine
• •Participants with neutropenia or thrombocytopenia
• •History of alcoholism or drug addiction within 1 year of screening
• •Self-reported history of smoking (tobacco, marijuana, or vaping) within the 7 days prior to initiation of study drug
• •Smokers not able to pass the tobacco-related laboratory screening and who cannot refrain from smoking during the confinement periods
• •Pregnancy or lactation
• •History of malignancy, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
• •Any severe bacterial, fungal, or parasitic infections associated with hospitalization or IV antibiotics within 1 year of screening
• •History of active parasitic infection within 6 months or exposure to water-born parasites within 6 weeks prior to initiation of study drug
• •Upper or lower respiratory tract infection within 4 weeks prior to screening
• •Received oral antibiotics within 4 weeks prior to initiation of study drug, or IV/intramuscular (IM) antibiotics within 8 weeks prior to initiation of study drug
• •For health volunteers: use of any prescription medications/products within 7 days prior to Day 1 and throughout the study
• •Use of any immunosuppressive medication within 30 days or 5 half-lives, whichever is greater, prior to initiation of study drug
• •Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to initiation of study drug (or within 5 half-lives of the investigational product, whichever is greater)
• •Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months or 5 half-lives, whichever is greater, prior to initiation of study drug
• •Received live or attenuated vaccine within 30 days prior to screening
• •Received killed vaccine within 14 days prior to initiation of study drug, unless deemed acceptable by the investigator and Sponsor
• •Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
• •Poorly controlled asthma
• •Use of any prescription medications and/or products other than asthma and/or allergic rhinitis medications within 7 days prior to Day 1 and throughout the study, unless deemed acceptable by the investigator and Sponsor
• •Active lung disease other than asthma
• •Occupations with potential exposure to exogenous sources of nitrous oxide and/or associated with elevated FeNO
• •Unable to perform FeNO measurement