NCT04872231

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

A Randomized, Double-Blind, Placebo Controlled, Single-Dose and Multiple Dose Dose-Ranging Study of Voriconazole Inhalation Powder in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (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 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.

Detailed description

This is a Phase 1, randomized, 2 part double-blind, placebo-controlled trial to evaluate the safety and PK profiles of Voriconazole Inhalation Powder (VIP) 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 Voriconazole Inhalation Powder or a matching placebo. Blood and sputum 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, with identical safety and PK procedures performed after minimum of 3 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 four different dose levels. Dose level 1 of Part B can begin in parallel once safety assessments of Part A dose level 2 are complete and indicate safety is present. Voriconazole Inhalation Powder will be administered twice daily (BID) × 13 doses. Blood samples for safety and PK will be collected over 12 hours after the first dose and 24 hours after the last dose. A minimum of 1 week will separate the start of each dose escalation, with the remaining dose groups.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Voriconazole Inhalation Powder	PART A (SAD): Voriconazole Inhalation Powder (VIP) will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period. SAD subjects will receive a single dose of study medication. Subjects in Cohort 1 will receive 10 mg, Cohort 2: 20 mg, Cohort 3: 40 mg, Cohort 4: 80 mg. PART B (MAD): Voriconazole Inhalation Powder (VIP) and will be administered with a will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period. MAD subjects will receive VIP BID for a total of 13 doses. Subjects in Cohort 1 will receive 10 mg BID, Cohort 2: 20 mg BID, Cohort 3: 40 mg BID, Cohort 4: 80 mg BID.
DRUG	Placebo	PART A (SAD): Placebo capsules will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period. Subjects in PART A will receive a single dose of placebo. PART B (MAD): Placebo will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period. Subjects in PART B will receive Placebo BID for a total of 13 doses.

Timeline

• Start date: 2019-11-22
• Primary completion: 2020-07-29
• Completion: 2020-08-26
• First posted: 2021-05-04
• Last updated: 2021-05-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study