The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers

Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and PK of single ascending doses of inhaled TLC19 in healthy volunteer subjects.

A Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and PK of single ascending doses of inhaled TLC19 (Hydroxychloroquine Liposome Inhalation Suspension) in healthy volunteer subjects. Three dose levels will be assessed in sequential cohorts, with 2 mL, 4 mL, and 6 mL. Total of approximately 30 subjects will be randomized in the study in 3 cohorts. Subjects will be enrolled and randomized to receiving either TLC19 or TLC 19 Vehicle.

Drug Administration: Blinded study medication will be administered through inhalation via a portable vibration mesh nebulizer.

Inclusion Criteria:

1. Male or female 18 to 65 years of age
2. Body mass index (BMI) 18.0 to 30.0 kg/m2.
3. Never-smoker

Exclusion Criteria:

1. Body weight <50 kg

2. Donation of blood (450 mL) or blood loss within 3 months prior to study

3. Contraindication, allergy, or hypersensitivity to hydroxychloroquine or chloroquine or other 4 aminoquinolines

4. Use of any prescription or OTC medications or herbal supplements within 2 weeks (or 5half-lives if longer) prior to study

5. Use of any investigational product/medical device within 30 days or 5 half-lives prior to study, or participation in ≥4 investigational drug studies within 1 year prior to study

6. History or presence of any of the following conditions:

   • Autoimmune or rheumatoid inflammatory disease
   • Cardiac disorders
   • Lung disease, prior intubation, or requiring use of an inhaler
   • Liver cirrhosis or Child-Pugh class C
   • Retinopathy or maculopathy
   • Neuromuscular diseases
   • Glucose-6 phosphate dehydrogenase deficiency
   • Hematologic malignancy
   • Chronic kidney disease or renal failure
   • Psoriasis or porphyria
   • Diabetes mellitus
   • Severe allergic or anaphylactic reactions
   • Any other significant condition that would preclude participation

7. History of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years

8. Fever or symptomatic viral or bacterial infection within 2 weeks prior to study

9. Any clinically significant laboratory abnormality