Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo
      controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating
      single doses of Niclosamide Inhalation Powder versus placebo (SAD part) and escalating
      multiple doses of Niclosamide Inhalation Powder versus placebo (MAD part). SAD part will be
      initiated first and includes a sentinel design. MAD part will not utilize a sentinel design
      unless the data monitoring committee requests the addition of sentinels. The MAD part will be
      initiated once the lowest doses from SAD part are deemed safe.
    

Detailed description: 
      This is a Phase 1, randomized, 2 part double-blind, placebo-controlled trial to evaluate the
      safety and PK profiles of Niclosamide Inhalation Powder in a SAD/MAD study design.

      Part A is a double-blinded, placebo-controlled, randomized, dose- ranging single dose study
      evaluating four different dose levels.

      On Day 1 of each group, two selected subjects (sentinel subjects) will receive either
      Niclosamide Inhalation Powder or a matching placebo. Blood samples and safety measurements
      including Adverse Events (AEs) will be collected over 24 hour period following the drug
      administration. The safety results to be evaluated include AEs, concomitant medications, out
      of specification clinical laboratory results, vital signs, Electrocardiograms (ECGs), visual
      examinations, pulmonary function tests, pulse oximetry results and any new findings on
      physical examinations. If the administration is safe as deemed by Principal Investigator &
      Medical Monitor, the remaining six subjects will be dosed (5 dosed with Niclosamide
      Inhalation Powder and 1 dosed with matching placebo), with identical safety and PK procedures
      performed after minimum of 2 days interval. A minimum of 3 days will separate each dose
      escalation, with the remaining dose groups dosed in a sentinel fashion.

      Part B is a double-blinded, placebo-controlled, randomized, dose- ranging multi-dose study
      evaluating two different dose levels. Dose level 1 of Part B can begin once the data
      monitoring committee reviews the safety data and indicates safety is present. Niclosamide
      Inhalation Powder will be administered twice daily (BID) × 9 doses. Blood samples for safety
      and PK will be collected throughout confinement, which is 7 days.
    

Intervention name(s): Niclosamide Inhalation Powder; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Investigational drug will be supplied as capsules, each capsule contains 0.25 mg or 1 mg of Niclosamide Inhalation Powder. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device.; Placebo will be supplied as capsules, each capsule will contain no active ingredient. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device.
Intervention MeSH terms: Niclosamide
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A: Eight (8) subjects will participate in each of the 3 dose escalations. Subjects will be randomized to receive either Niclosamide Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8).
Part B: Eight (8) subjects will participate in each of the 2 dose escalations. Subjects will be randomized to receive either Niclosamide Inhalation Powder or placebo by inhalation (6 active, 2 placebo per group of 8).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science