A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants

Exclusion Criteria

• •1. History of clinically significant (as per Investigator's judgment) upper respiratory disease or history of any significant pulmonary disease including, but not limited to, asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and history of previous tuberculosis exposure with positive interferon gold test (without actual infection).
• •2. Participants with any history of, or active, clinically significant disease (e.g., cardiovascular disease, chronic liver disease, psychiatric medical history, renal disease) that could interfere with the interpretation of the study results or compromise the health of the participant based on the judgment of the Investigator.
• •3. Administration of vaccines/immunizations and/or boosters within 8 days prior to first dosing or if planned during the study.
• •4. Any history of active infection at the time of Screening and/or within 28 days prior to first dosing.
• •5. Any prior participation in a study with an investigational drug or device involving a biological targeted therapy, where final administration of the investigational drug or utilization of the device occurred within 24 weeks prior to first dosing.
• •6. History of migraine headaches requiring prescription medication or occurring more than 2-4 times per month within the past 6 months.
• •7. Use of non-tobacco vaping within 12 months prior to Screening.
• •8. Use of any tobacco and/or inhaled marijuana product within 2 years prior to Screening.