Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution

Exclusion Criteria

• •1. Clinically significant physical findings, vital signs, ECG, or laboratory values that could interfere with the objectives of the study or the safety of the subject.
• •2. Pregnant or lactating or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
• •3. Presence of acute or chronic illness or history of chronic illness.
• •4. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary artery disease, or history of any psychotic mental illness.
• •5. Upper or lower respiratory tract infection within 4 weeks before the first dose of treatment.
• •6. Any medically identified respiratory disease(s) and/or condition(s), including but not limited to current asthma, chronic obstructive pulmonary disease, and diagnosed obstructive sleep apnoea syndrome.
• •7. Any clinically significant arrhythmia(s) at Screening ECG.
• •8. History of surgery or medical intervention, or planned surgery or medical intervention, that could interfere with the objectives of the study or the safety of the volunteer.
• •9. Currently taking any drug including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days before the first dose and throughout the study, with the exception of acetylsalicylic acid (aspirin).
• •10. Positive test result(s) for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HbsAg), human immunodeficiency virus (HIV) antibody, or coronavirus disease of 2019 (COVID-19).
• •11. Suffering from post-COVID-19 syndrome or have tested positive for COVID-19 infection within 3 months prior to the first dose of treatment.
• •12. Participation in another clinical study of a new chemical entity, new device, or a prescription medicine within 3 months before dosing.
• •13. Regular alcohol consumption at levels which may increase risk of harm from alcohol-related disease or injury. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and for the duration of the study.
• •14. A history of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years, or a positive toxicology screening panel (urine test including qualitative identification of barbiturates, THC, amphetamines, methamphetamines, MDMA, phencyclidine, benzodiazepines, opiates and cocaine), or alcohol breath test.
• •15. Current or previous use of tobacco, nicotine products, vaping device or e-cigarettes within the past 6 months.
• •16. Loss of more than 400 mL blood (e.g., as a blood donor, or donor of blood products), during the 3 months before screening.
• •17. Received any vaccination (e.g. for COVID-19 or influenza) within 6 weeks of treatment or plans to receive a vaccination during the study.
• •18. History of Mycobacterium tuberculosis infection, or latent M. tuberculosis infection.
• •19. Active or latent parasitic infection, have travelled to or have an intention to travel to a country with a high prevalence of parasitic infections within 3 months before or after receiving the treatment.
• •20. Evidence of any other clinically significant infection, including bacterial or viral infections, at Screening and Day -1.
• •21. Presence of any underlying physical and/or psychological medical condition that would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
• •22. An employee of the study site or Sponsor who is directly involved in the study, or a family member of such a person.