Status:
COMPLETED
The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
Lead Sponsor:
Taiwan Liposome Company
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
Detailed Description
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 hea...
Eligibility Criteria
Inclusion
- Male or female 18 to 65 years of age
- Body mass index (BMI) 18.0 to 30.0 kg/m2.
- Never-smoker
Exclusion
- Body weight \<50 kg
- Donation of blood (450 mL) or blood loss within 3 months prior to study
- Contraindication, allergy, or hypersensitivity to hydroxychloroquine or chloroquine or other 4 aminoquinolines
- Use of any prescription or OTC medications or herbal supplements within 2 weeks (or 5half-lives if longer) prior to study
- 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
- 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
- History of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years
- Fever or symptomatic viral or bacterial infection within 2 weeks prior to study
- Any clinically significant laboratory abnormality
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04697654
Start Date
October 8 2020
End Date
June 18 2021
Last Update
November 26 2021
Active Locations (1)
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1
Mackay Memorial Hospital Tamsui Branch
Taipei, Taiwan, 10449