NCT04802746

A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover (Part A) and 2-Arm Parallel Group (Part B) Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants (Part A) and in Study Participants With Mild Asthma (Part B)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the pulmonary safety of Staccato alprazolam in healthy study participants and in and study participants with mild asthma

Conditions

• Healthy Study Participants
• Participants With Mild Asthma

Interventions

Type	Name	Description
DRUG	Alprazolam	Study participants will receive Staccato alprazolam Dose 1 and Staccato alprazolam Dose 2 at pre-specified time points in Part A. Study participants will receive single dose of Staccato alprazolam at pre-specified time points in Part B.
OTHER	Placebo	Study participants will receive Staccato placebo at pre-specified time points in Part A and Part B matching the pre-specified Staccato alprazolam dosing.

Timeline

• Start date: 2021-03-09
• Primary completion: 2021-11-22
• Completion: 2021-11-22
• First posted: 2021-03-17
• Last updated: 2023-11-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study