Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects
Status:
Recruiting
Trial end date:
2022-01-24
Target enrollment:
Participant gender:
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.