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

• Status: Completed
• Trial end date: 2021-06-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taiwan Liposome Company
• Treatments: Hydroxychloroquine

Criteria

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