Norketotifen for the Treatment of Uncomplicated Influenza-like Illness

Exclusion Criteria

• •1. Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
• •2. Severe ILI requiring inpatient treatment
• •3. Any of the following risk factors (according to the CDC's list of People at High Risk for Developing Serious Flu-Related Complications):
• •* Residents of nursing homes or other long-term care facilities
• •* American Indians and Alaska natives
• •* Asthma
• •* Chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
• •* Neurological and neurodevelopmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy \[seizure disorders\], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
• •* Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
• •* Blood disorders (such as sickle cell disease)
• •* Endocrine disorders (such as diabetes mellitus)
• •* Kidney disorders
• •* Liver disorders
• •* Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
• •* Compromised immune system due to disease or medication (such as subjects with human immunodeficiency virus or cancer, or those on chronic steroids)
• •* Extreme obesity (body mass index ≥40 kg/m\^2)
• •4. Presence of any severe or uncontrolled medical or psychiatric illness
• •5. History of or current autoimmune disease
• •6. History of recurrent lower respiratory tract infection
• •7. Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
• •8. Female subjects who are pregnant or breastfeeding
• •9. Any clinically significant electrocardiogram test
• •10. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
• •11. Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
• •12. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
• •13. Exposure to an investigational drug within 30 days prior to the pre-dose examinations
• •14. History of allergic reaction to ketotifen
• •15. Any prior exposure to norketotifen