A Study of Efficacy and Safety of AX-8 in Chronic Cough

Exclusion Criteria

• •Positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
• •Current smoker (including e-cigarettes), individuals who have given up smoking within the past 12 months, or individuals with a smoking history of 20 pack-years
• •Treatment with an ACE-inhibitor as the potential cause of a subject's cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
• •History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks
• •History of cystic fibrosis
• •Positive test for any drug of abuse
• •History of malignancy within 5 years prior to the Baseline Visit
• •History of infection or known active infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
• •History of hypersensitivity or intolerance to AX-8 or other TRPM8 agonists or any of the excipients