drugset
drugset / Trial / NCT04872231

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

NCT04872231 ↗

Phase 1 Completed 65 enrolled TFF Pharmaceuticals, Inc.
RandomizedSequentialDouble-blindBasic science

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 Voriconazole Inhalation Powder versus placebo (SAD part) and escalating multiple doses of Voriconazole 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 and will be initiated once the lowest doses from SAD part are deemed safe.

Timeline

Start
2019-11-22
Primary completion
2020-07-29
Completion
2020-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Voriconazole Small molecule 10 mg Inhaled
Subject Voriconazole Small molecule 20 mg Inhaled
Subject Voriconazole Small molecule 40 mg Inhaled
Subject Voriconazole Small molecule 80 mg Inhaled

Indications

No indication recorded.