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NCT04802746 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma
A Phase 1 study of Healthy Study Participants and Participants With Mild Asthma, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 2
- Study locations
NCT04802746: Completed Phase 1 study of Healthy Study Participants and Participants With Mild Asthma, sponsored by UCB Biopharma SRL.
NCT04802746 is a Phase 1 study of Healthy Study Participants and Participants With Mild Asthma that has completed, run by UCB Biopharma SRL. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04802746, a Phase 1 study of Healthy Study Participants and Participants With Mild Asthma, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 2
- Study locations
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
Primary Outcome
The maximum mean treatment difference between each Staccato alprazolam dose and placebo in change from Baseline in Forced Expiratory Volume in 1 second (FEV1) will be calculated for dosing day 1 over each Treatment Period from Baseline to 6 hours postdose in Part A.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Alprazolam
Study Locations (2)
Massachusetts
- Up0099 101 - North Dartmouth
North Carolina
- Up0099 102 - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 1 |
What the finished NCT04802746 record still lists
NCT04802746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 2 conditions, with Healthy Study Participants appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04802746 reports a single indexed study location in Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04802746 about?
NCT04802746 is a clinical study titled "A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma". 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
What is the current status of trial NCT04802746?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2021-03-09. Estimated completion is 2021-11-22.
What conditions does trial NCT04802746 study?
This clinical trial studies the following conditions: Healthy Study Participants, Participants With Mild Asthma.
What interventions are being tested in trial NCT04802746?
The interventions under investigation include: Placebo (OTHER), Alprazolam (DRUG).
Who is sponsoring clinical trial NCT04802746?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04802746 being conducted?
This trial has 2 study locations across Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04802746's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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