Clinical trial NCT04697654: The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: hydroxychloroquine
Inhalation
Lead sponsor: Taiwan Liposome Company
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Incidence of AEs
timeFrame: 0-28 Days
Secondary outcomes:
measure: Maximum blood concentration
timeFrame: 0-168 hours
measure: Time to reach maximum blood concentration
timeFrame: 0-168 hours
measure: Area under the blood concentration-time curve
timeFrame: 0-168 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital Tamsui Branch
Study officials:
affiliation: Taiwan Liposome Company, Ltd.
name: Carl Brown, PhD
role: STUDY_DIRECTOR
References: