NCT05168644

Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects

Phase 1, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and Pharmacokinetics Trial of Inhaled Niclosamide in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: TFF Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Niclosamide Inhalation Powder	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.
DRUG	Placebo	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.

Timeline

• Start date: 2021-11-14
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2021-12-23
• Last updated: 2022-02-02

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study