Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)

Main Inclusion Criteria:

- Written informed consent and HIPAA

- Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a
body weight >50 kg

- General good health

- Ability to use oral inhaler

Main Exclusion Criteria:

- Pregnancy, breast feeding, intention to become pregnant during the course of the
study or lack of safe contraception in pre-menopausal women

- Participation in any investigational drug trial within the 30 days before Screening
Visit and thereafter

- History or current clinically relevant allergies or idiosyncrasy to drugs or food

- History of allergic reactions to any corticosteroids including ciclesonide or any
excipients of the formulations

- Any contraindication to nasally administered corticosteroids

- History of a respiratory infection or disorder [including, but not limited to
bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory
syndrome (SARS)] within the 30 days before Screening Visit, or development of a
respiratory infection during the Screening Period

- History or current evidence of any other relevant allergic, cardiovascular,
pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic,
neurological, psychiatric, or other disease within the last 2 years

- Non-vaccinated exposure to or active infection with, chickenpox or measles within the
21 days preceding Screening Visit