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

NCT07020988 | Completed Phase 1 FDA Drug

• 1 other identifier: UP0127
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Phase 1; Staccato alprazolam; midazolam; diazepam; Healthy Study Participants

Outcome Measures

Primary Outcomes (2)

• Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 minutes of study intervention administration of Staccato alprazolam in Group 1

  Time to reach a z-score of absolute power \>2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the quantitative electroencephalogram (qEEG) data recorded for each study participant.

  Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1

• Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 minutes of study intervention administration of iv midazolam in Group 1

  Time to reach a z-score of absolute power \>2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the quantitative electroencephalogram (qEEG) data recorded for each study participant.

  Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1

Secondary Outcomes (13)

• Occurrence of Treatment Emergent Adverse Events (TEAEs) from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)

  From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)

• Occurrence of Serious TEAEs from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)

  From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)

• Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 Minutes of study intervention administration of Staccato alprazolam in Group 2

  Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2

• Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 Minutes of study intervention administration of nasal diazepam in Group 2

  Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2

• Maximum concentration (Cmax) of alprazolam

  Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

Study Arms (5)

Pilot Part

EXPERIMENTAL

Study participants who successfully completed the Screening Period will receive single dose of Intravenous (IV) midazolam on Day 1 of the Intervention Period.

Drug: Midazolam

Main Part-Group 1: Treatment Sequence AB

EXPERIMENTAL

Study participants randomized in Group 1 will receive Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 1 followed by Treatment B: IV Midazolam on Day 1 of the Intervention Period 2.

Drug: Staccato Alprazolam; Drug: Midazolam

Main Part-Group 1: Treatment Sequence BA

EXPERIMENTAL

Study participants randomized in Group 1 will receive Treatment B: IV Midazolam on Day 1 of the Intervention Period 1 followed by Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 2.

Drug: Staccato Alprazolam; Drug: Midazolam

Main Part-Group 2: Treatment Sequence AC

EXPERIMENTAL

Study participants randomized in Group 2 will receive Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 1 followed by Treatment C: Nasal Diazepam on Day 1 of the Intervention Period 2.

Drug: Staccato Alprazolam; Drug: Diazepam

Main Part-Group 2: Treatment Sequence CA

EXPERIMENTAL

Study participants randomized in Group 2 will receive Treatment C: Nasal Diazepam on Day 1 of the Intervention Period 1 followed by Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 2.

Drug: Staccato Alprazolam; Drug: Diazepam

Interventions

Staccato Alprazolam DRUG

Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.

Also known as: UCB7538

Main Part-Group 1: Treatment Sequence AB; Main Part-Group 1: Treatment Sequence BA; Main Part-Group 2: Treatment Sequence AC; Main Part-Group 2: Treatment Sequence CA

Midazolam DRUG

Study participants will receive single dose of IV Midazolam at pre-specified time points.

Main Part-Group 1: Treatment Sequence AB; Main Part-Group 1: Treatment Sequence BA; Pilot Part

Diazepam DRUG

Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.

Main Part-Group 2: Treatment Sequence AC; Main Part-Group 2: Treatment Sequence CA

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be 20 years to 55 years of age, inclusive, at the time of signing the ICF.
• Participant is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring, at the Screening Visit and on Day -1 of the single Intervention Period for the Pilot Part or on Day -1 of the first Intervention Period for the Main Part of the study.
• Participant has a bodyweight of at least 45 kilograms (kg) (female) and 50 kg (male) and a body mass index within the range of 18 Kilograms per meter square (Kg/m2) to 30 kg/m2 (inclusive)
• Participant has given informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.

You may not qualify if:

• Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study.
• Participant has a history of chronic alcohol or drug abuse, as defined in the most recent version of the Diagnostic and Statistical Manual of Mental Disorders, within 6 months prior to the Screening Visit.
• Participant has a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• Participant has a history of or has been diagnosed with epilepsy or epileptic seizures.
• Participant has abnormal EEG findings at Screening including background slowing (\<8Hz), focal slowing (focal δ-activity), or epileptiform discharges.

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Up0127 1001

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

Midazolam; Diazepam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepinones

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 12, 2025
• Primary Completion: January 6, 2026
• Study Completion: January 21, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)