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

NCT04802746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-11-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2021-11-22
Completion
2021-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802746 on ClinicalTrials.gov