A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers

Exclusion Criteria

• •1. Any self-reported symptoms of influenza-like or COVID-19-like illness in the 14 days preceding the study visit: Fever \>101.4 °F, sore throat, nasal congestion, post-nasal discharge, shortness of breath, gastrointestinal distress, wheezing, cough, headache, or fatigue.
• •2. Any history of diagnosed chronic lung disease, including but not limited to asthma or chronic obstructive lung disease.
• •3. Symptoms of seasonal allergies or use of any drugs for seasonal allergies or any inhaled (oral/nasal) drugs in the 2 weeks prior to Day 1. Mild seasonal allergy symptoms that have not altered sleep or activity patterns nor required use of over-the-counter (OTC) or prescription medications are allowed.
• •4. Any close contact exposure in the past 28 days to a person who was diagnosed as having COVID-19, with or without laboratory confirmation, during that close contact exposure or in the ensuing 14 days OR a similar encounter with a person who was determined to have suspected COVID-19, defined by that person being ordered to enter isolation for that indication by a medical authority. Close contact is defined as being within approximately 6 feet of a COVID-19 case for a prolonged (\>10 minutes) period of time and can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 patient OR having direct contact with infectious secretions of a COVID-19 patient (e.g., being coughed on), if such contact occurred while not wearing the recommended personal protective equipment for that type of contact \[e.g., gowns, gloves, N95 respirator (or equivalent), eye protection\].
• •5. Any participant with a history of SARS-CoV-2 infection that was confirmed by testing or diagnosed without testing within 4 weeks preceding Day 1. If infection occurred more than 4 weeks prior, candidates may be enrolled if they meet the rest of the eligibility criteria.
• •6. Any participant with a history severe respiratory illness that required hospitalization in the 60 days preceding Day 1 OR any participant with a history severe respiratory illness that required hospitalization in the preceding 120 days without full recovery.
• •7. Participation in another clinical study that involved treatment with an investigational product or device within 30 days of screening or during the study.
• •8. Participants with a known history of human immunodeficiency virus (HIV) infection.
• •9. Known, active hepatitis A, B, or C infection.
• •10. History of bronchospasm in response to use of an inhalation device.
• •11. Use of any prescription medication (except oral contraceptives) during the 30 days prior to study dosing that may affect drug absorption, metabolism and excretion, prolong the QTc interval, affect drug efficacy, or increase the risk of adverse reactions, unless approved by the Principal Investigator.
• •12. Use of any OTC product, herbal product, diet aid, hormone supplement, etc., within 7 days prior to dosing unless approved by the Principal Investigator.
• •13. Unwilling or unable to provide written informed consent.
• •14. Any known hypersensitivity to quinolines (e.g., hydroxychloroquine, chloroquine, primaquine, quinine) or known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or any contraindication to oral hydroxychloroquine.
• •15. Known retinopathy, fundus disease, or macular disease.
• •16. Diagnosis of long QT Syndrome.
• •17. Smoking of tobacco or non-tobacco substances, or vaping, within the last 6 months.
• •18. Severe obesity (body mass index \[BMI\] ≥35 kg/m2).