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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Hydroxychloroquine Liposome Inhalation Suspension
Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)
Mackay Memorial Hospital Tamsui Branch
Taipei, Taiwan
Incidence of AEs
To evaluate the severity, seriousness, outcome, and action taken of AE
Time frame: 0-28 Days
Maximum blood concentration
Cmax
Time frame: 0-168 hours
Time to reach maximum blood concentration
Tmax
Time frame: 0-168 hours
Area under the blood concentration-time curve
AUC0-last
Time frame: 0-168 hours
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