NCT07020988

A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants

An Open Label, Single Dose, Randomized, Active Comparator, Quantitative Electroencephalogram Crossover Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Intravenous Midazolam and of Staccato Alprazolam Versus Nasal Diazepam in Healthy Study Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to estimate the difference in the time to onset of action between Staccato alprazolam and intravenous (iv) midazolam using changes in power in the combined spindle and β1 frequency bands in the qEEG (quantitative electroencephalogram).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Staccato Alprazolam	Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.
DRUG	Midazolam	Study participants will receive single dose of IV Midazolam at pre-specified time points.
DRUG	Diazepam	Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-01-06
• Completion: 2026-01-21
• First posted: 2025-06-13
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study