NCT05168644 is a Phase 1 clinical trial of Niclosamide Inhalation Powder in Healthy, sponsored by TFF Pharmaceuticals, Inc..

Who is sponsoring NCT05168644?

NCT05168644 is sponsored by TFF Pharmaceuticals, Inc..

What drugs are being tested in NCT05168644?

Interventions in NCT05168644: Niclosamide Inhalation Powder, Placebo.

Is NCT05168644 still recruiting?

NCT05168644 is currently completed. Last updated 2 February 2022.

Last reviewed 2022-02-02 · How we verify

NCT05168644

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 2 February 2022

What this trial tests

Phase 1 trial testing Niclosamide Inhalation Powder in Healthy in 40 participants. Completed in 26 January 2022.

Timeline

14 November 2021

Primary endpoint
26 January 2022

26 January 2022

Quick facts

Lead sponsor	TFF Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	basic science
Enrollment	40
Start date	14 November 2021
Primary completion	26 January 2022
Estimated completion	26 January 2022
Sites	1 location across Canada

Drugs / interventions tested

Niclosamide Inhalation Powder — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

TFF Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other TFF Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT05501574 — An Open Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetic Profile of Tacrolimus Inhalation P · Phase 2 · terminated
NCT04576325 — Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma · Phase 1 · completed
NCT04872231 — Single Ascending Dose and Multiple Ascending Dose Study of Voriconazole Inhalation Powder in Healthy Adult Subjects · Phase 1 · completed
NCT05897294 — Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05168644 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TFF Pharmaceuticals, Inc.
Last refreshed: 2 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05168644.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing