Healthy Study ParticipantsPhase 1NCT04802746
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 testing Alprazolam in people with Healthy Study Participants and Participants With Mild Asthma, run by UCB Biopharma SRL at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants, Participants With Mild Asthma
- What is being tested?
- Alprazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Mar 2021to 22 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A: Healthy study participants
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF)
- Participants are overtly healthy at Screening and on Day -1 of each Treatment Period as determined by medical evaluation including medical history and physical examination
- Participant has a body weight of at least 45 kg (female) and 50 kg (male) and body mass index (BMI) within the range 18 to 35 kg/m^2 (inclusive)
- Participants may be male or female A male participant must agree to use contraception during the Treatment Periods and for at least 7 days after the last dose of study treatment and must refrain from donating sperm during this period
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
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- Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Periods and for at least 30 days after the last dose of study treatment
- Participant is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol
- Participant has normal spirometry at Screening as demonstrated by forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) ≥ 90% of predicted. In case of an out-of-range result, 1 repeat test will be allowed. If the readings are out-of-range again, the study participant will be excluded
- Part B: Study participants with mild asthma
- Participant must be 18 to 55 years of age inclusive, at the time of signing the ICF
- Participant has a documented history of mild asthma diagnosed at least 6 months prior to the Screening Visit in accordance with the Global Initiative for Asthma (GINA) Guidelines 2020 and/or the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 Guidelines 2007. The diagnosis of mild asthma can be documented by various sources of medical information including, but not limited to, the participant's medical record, prescriptions of asthma treatments, and/or previous spirometry assessments (including FEV1 reversibility after short-acting beta2-agonist (SABA) administration)
- Participant has been on a stable asthma drug regimen (as needed short-acting beta2-agonist (SABA)s or combination low dose inhaled corticosteroids (ICS)-formoterol and maintenance treatment with daily low dose ICS or daily leukotriene receptor antagonists) for at least 4 weeks before the Screening Visit
- Participant has normal breathing sounds during normal tidal breathing on lung auscultation
- Participant has a percent predicted forced expiratory volume in 1 second (ppFEV1) value at Screening ≥80%. Before performing spirometric assessments at Screening, a washout period of at least 6 hours is required after the last SABA intake and is extended to at least 18 hours after the last intake of the combination low dose ICS-formoterol. In case of an out-of-range result, 1 repeat test will be allowed. If the readings are out of range again, the study participant will be excluded
Who cannot join
- Part A: Healthy study participants
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has had a positive test for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) or clinical signs/symptoms consistent with coronavirus disease 2019 (COVID-19) such as fever, persistent cough, shortness of breath, fatigue, and loss or change to senses of smell or taste during the 4 weeks prior to Screening or Day -1 of the first Treatment Period.
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs (and/or an investigational device) as stated in this protocol
- Participant has a known hypersensitivity to albuterol or similar short-acting beta2-agonist (SABA) that may be used as rescue medication administered in response to potential bronchospasm
- Participant has a history of acute narrow angle glaucoma, hydrocephalus, or Myasthenia gravis
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- Participant has received or intends to use any prescription or nonprescription medicines, including enzyme inhibitors or inducers, over the counter remedies, and herbal and dietary supplements (including St. John's Wort) up to 2 weeks or 5 half-lives of the respective drug (whichever is longer) before the first administration of IMP and during the clinical part of the study, unless required to treat an adverse event (AE). This does not include oral contraceptives not exceeding 30 μg ethinyl estradiol or postmenopausal hormone replacement therapy or implants, patches, or intrauterine devices (IUDs)/intrauterine hormone-releasing systems (IUSs) delivering progesterone (for female study participants)
- Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study
- Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days before Screening (or 5 half-lives, whichever is longer) or is currently participating in another study of an IMP (and/or an investigational device)
- Participant has a SpO2 measured by pulse oximetry <95% for >30 seconds at Screening and on day -1 of each Treatment Period. In case of an out-of-range result, 1 repeat test will be allowed. If the readings are out- of- range again, the study participant will be excluded
- Participant has a history or current condition characterized by airway hyperresponsiveness (eg, asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, obstructive sleep apnea, pneumothorax, etc) at Screening and on Day -1 of each Treatment Period
- Participant has contraindications for spirometry at Screening and on Day -1 of each Treatment Period (eg, history of myocardial infarction within 1 week, systemic hypotension, severe hypertension, significant atrial/ventricular arrhythmia, uncompensated heart failure, uncontrolled pulmonary hypertension, acute cor pulmonale, clinically unstable pulmonary embolism, history of syncope related to forced expiration/cough, history of cerebral aneurism, brain surgery within 4 weeks, recent concussion with continuing symptoms, eye surgery within 1 week, sinus surgery or middle ear surgery or infection within 1 week, presence of pneumothorax, thoracic surgery within 4 weeks, abdominal surgery within 4 weeks, late-term pregnancy, active or suspected transmissible respiratory or systemic infection, including tuberculosis within 4 weeks, physical conditions predisposing to transmission of infections, such as hemoptysis, significant secretions or oral lesions or oral bleeding; acute illness 5 days before Screening, upper respiratory tract infection in the 4 weeks before Screening)
- Part B: Study participants with mild asthma
- Participant is taking a prohibited medication or has taken a prohibited medication as defined in the Protocol
- Participant has a history of or current respiratory disease characterized by airway hyperresponsiveness excluding asthma (eg, COPD, pulmonary fibrosis, obstructive sleep apnea, pneumothorax, etc)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Up0099 101
North Dartmouth, Massachusetts, 02747
Up0099 102
Raleigh, North Carolina, 27607
About this study
Official title: 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)
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
- Being tested
- Alprazolam, Placebo
- Keywords
- Healthy Study Participants, Staccato alprazolam, Phase 1, Pulmonary Safety, Alprazolam, STAP-001, Mild asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Also called UCB7538
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.
PlaceboOther
Also called PBO
Study participants will receive Staccato placebo at pre-specified time points in Part A and Part B matching the pre-specified Staccato alprazolam dosing.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC in Part A | Experimental | Study participants randomized to this arm will receive Staccato Placebo (A) and two fixed doses of Staccato alprazolam Dose 1 (B) and Staccato alprazolam Dose 2 (C) at pre-specified time points during 3 separate Treatment Periods in Part A. Receives: Drug: Alprazolam; Other: Placebo |
| Sequence BCA in Part A | Experimental | Study participants randomized to this arm will receive Staccato alprazolam Dose 1 (B), Staccato alprazolam Dose 2 (C), and Staccato Placebo (A) at pre-specified time points during 3 separate Treatment Periods in Part A. Receives: Drug: Alprazolam; Other: Placebo |
| Sequence CAB in Part A | Experimental | Study participants randomized to this arm will receive Staccato alprazolam Dose 2 (C), Staccato Placebo (A), and Staccato alprazolam Dose 1 (B) at pre-specified time points during 3 separate Treatment Periods in Part A. Receives: Drug: Alprazolam; Other: Placebo |
| Sequence ACB in Part A | Experimental | Study participants randomized to this arm will receive Staccato Placebo (A), Staccato alprazolam Dose 2 (C), and Staccato alprazolam Dose 1 (B) at pre-specified time points during 3 separate Treatment Periods in Part A. Receives: Drug: Alprazolam; Other: Placebo |
| Sequence BAC in Part A | Experimental | Study participants randomized to this arm will receive Staccato alprazolam Dose 1 (B), Staccato Placebo (A), and Staccato alprazolam Dose 2 (C) at pre-specified time points during 3 separate Treatment Periods in Part A. Receives: Drug: Alprazolam; Other: Placebo |
| Sequence CBA in Part A | Experimental | Study participants randomized to this arm will receive Staccato alprazolam Dose 2 (C), Staccato alprazolam Dose 1 (B), and Staccato Placebo (A) at pre-specified time points during 3 separate Treatment Periods in Part A. Receives: Drug: Alprazolam; Other: Placebo |
| Staccato alprazolam in Part B | Experimental | Study participants randomized to this arm will receive Staccato alprazolam at pre-specified time points in Part B. Receives: Drug: Alprazolam |
| Staccato placebo in Part B | Placebo comparator | Study participants randomized to this arm will receive Staccato placebo at pre-specified time points in Part B. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 1 in Part A
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.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 4 in Part A
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 days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part A.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Percentage of study participants with respiratory treatment-emergent adverse events (TEAEs) in Part A
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved except for events in users or other persons, which only include events related to investigational devices.
Measured: From Baseline (Day 1) to Safety Follow-up period (up to Day 44)
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 1 in Part B
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 B.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 4 in Part B
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 days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part B.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Percentage of study participants with respiratory treatment-emergent adverse events (TEAEs) in Part B
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved except for events in users or other persons, which only include events related to investigational devices.
Measured: From Baseline (Day 1) to Safety Follow-up period (up to Day 14)
Secondary outcomes (16)
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 1 in Part A
The maximum mean treatment difference between each Staccato alprazolam dose and placebo in change from Baseline in Forced Vital Capacity (FVC) will be calculated for dosing day 1 over each Treatment Period from Baseline to 6 hours postdose in Part A.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 4 in Part A
The maximum mean treatment difference between each alprazolam dose and placebo in change from Baseline in Forced Vital Capacity (FVC) will be calculated for dosing days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part A.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 1 in Part A
The maximum mean treatment difference between each alprazolam dose and placebo in change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio will be calculated for dosing day 1 over each Treatment Period from Baseline to 6 hours postdose in Part A.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 4 in Part A
The maximum mean treatment difference between each alprazolam dose and placebo in change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio will be calculated for dosing days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part A.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part A
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved except for events in users or other persons, which only include events related to investigational devices.
Measured: From Baseline (Day 1) to Safety Follow-up Period (up to Day 44)
Maximum plasma concentration (Cmax) of Staccato alprazolam in Part A
Cmax = maximum plasma concentration
Measured: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of Staccato alprazolam in Part A
AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration
Measured: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Area under the plasma concentration-time curve from time 0 to infinity (AUC) of Staccato alprazolam in Part A
AUC = Area under the plasma concentration-time curve from time 0 to infinity
Measured: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 1 in Part B
The maximum mean treatment difference between each Staccato alprazolam dose and placebo in change from Baseline in Forced Vital Capacity (FVC) will be calculated for dosing day 1 over each Treatment Period from Baseline to 6 hours postdose in Part B.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 4 in Part B
The maximum mean treatment difference between each alprazolam dose and placebo in change from Baseline in Forced Vital Capacity (FVC) will be calculated for dosing days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part B.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 1 in Part B
The maximum mean treatment difference between each alprazolam dose and placebo in change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio will be calculated for dosing day 1 over each Treatment Period from Baseline to 6 hours postdose in Part B.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 4 in Part B
The maximum mean treatment difference between each alprazolam dose and placebo in change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio will be calculated for dosing days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part B.
Measured: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part B
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved except for events in users or other persons, which only include events related to investigational devices.
Measured: From Baseline (Day 1) to Safety Follow-up Period (up to Day 14)
Maximum plasma concentration (Cmax) of Staccato alprazolam in Part B
Cmax = maximum plasma concentration
Measured: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of Staccato alprazolam in Part B
AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration
Measured: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Area under the plasma concentration-time curve from time 0 to infinity (AUC) of Staccato alprazolam in Part B
AUC = Area under the plasma concentration-time curve from time 0 to infinity
Measured: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start9 Mar 2021
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Part A of the Study will be 3-Way Crossover Design and Part B will be a Parallel Design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802746
- Sponsor's protocol ID
- UP0099
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Publications
Miller SD, LaForce CF, Barlow L, Watanabe S, King A, Burian M, Chanteux H. Pulmonary safety of Staccato alprazolam in healthy participants and participants with mild asthma: Phase 1, randomized, double-blind, placebo-controlled trial. Pulm Pharmacol Ther. 2026 Jun;93:102411. doi: 10.1016/j.pupt.2026.102411. Epub 2026 Feb 24.
PubMed 41747804
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04802746
- Acronym / sponsor ID
- UP0099
- Keywords
- Healthy Study Participants, Staccato alprazolam, Phase 1, Pulmonary Safety, Alprazolam, STAP-001, Mild asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Part A of the Study will be 3-Way Crossover Design and Part B will be a Parallel Design.
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC in Part A | Experimental | Drug: Alprazolam, Other: PlaceboStudy participants randomized to this arm will receive Staccato Placebo (A) and two fixed doses of Staccato alprazolam Dose 1 (B) and Staccato alprazolam Dose 2 (C) at pre-specified time points during 3 separate Treatment Periods in Part A. |
| Sequence BCA in Part A | Experimental | Drug: Alprazolam, Other: PlaceboStudy participants randomized to this arm will receive Staccato alprazolam Dose 1 (B), Staccato alprazolam Dose 2 (C), and Staccato Placebo (A) at pre-specified time points during 3 separate Treatment Periods in Part A. |
| Sequence CAB in Part A | Experimental | Drug: Alprazolam, Other: PlaceboStudy participants randomized to this arm will receive Staccato alprazolam Dose 2 (C), Staccato Placebo (A), and Staccato alprazolam Dose 1 (B) at pre-specified time points during 3 separate Treatment Periods in Part A. |
| Sequence ACB in Part A | Experimental | Drug: Alprazolam, Other: PlaceboStudy participants randomized to this arm will receive Staccato Placebo (A), Staccato alprazolam Dose 2 (C), and Staccato alprazolam Dose 1 (B) at pre-specified time points during 3 separate Treatment Periods in Part A. |
| Sequence BAC in Part A | Experimental | Drug: Alprazolam, Other: PlaceboStudy participants randomized to this arm will receive Staccato alprazolam Dose 1 (B), Staccato Placebo (A), and Staccato alprazolam Dose 2 (C) at pre-specified time points during 3 separate Treatment Periods in Part A. |
| Sequence CBA in Part A | Experimental | Drug: Alprazolam, Other: PlaceboStudy participants randomized to this arm will receive Staccato alprazolam Dose 2 (C), Staccato alprazolam Dose 1 (B), and Staccato Placebo (A) at pre-specified time points during 3 separate Treatment Periods in Part A. |
| Staccato alprazolam in Part B | Experimental | Drug: AlprazolamStudy participants randomized to this arm will receive Staccato alprazolam at pre-specified time points in Part B. |
| Staccato placebo in Part B | Placebo comparator | Other: PlaceboStudy participants randomized to this arm will receive Staccato placebo at pre-specified time points in Part B. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Part A: Healthy study participants
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF)
- Participants are overtly healthy at Screening and on Day -1 of each Treatment Period as determined by medical evaluation including medical history and physical examination
- Participant has a body weight of at least 45 kg (female) and 50 kg (male) and body mass index (BMI) within the range 18 to 35 kg/m^2 (inclusive)
- Participants may be male or female A male participant must agree to use contraception during the Treatment Periods and for at least 7 days after the last dose of study treatment and must refrain from donating sperm during this period
Key exclusion criteria (15 listed)
- Part A: Healthy study participants
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has had a positive test for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) or clinical signs/symptoms consistent with coronavirus disease 2019 (COVID-19) such as fever, persistent cough, shortness of breath, fatigue, and loss or change to senses of smell or taste during the 4 weeks prior to Screening or Day -1 of the first Treatment Period.
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs (and/or an investigational device) as stated in this protocol
- Participant has a known hypersensitivity to albuterol or similar short-acting beta2-agonist (SABA) that may be used as rescue medication administered in response to potential bronchospasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlprazolamAlso: UCB7538Study 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. | Drug | Sequence ABC in Part A, Sequence ACB in Part A, Sequence BAC in Part A, Sequence BCA in Part A, Sequence CAB in Part A, Sequence CBA in Part A, Staccato alprazolam in Part B |
| PlaceboAlso: PBOStudy participants will receive Staccato placebo at pre-specified time points in Part A and Part B matching the pre-specified Staccato alprazolam dosing. | Other | Sequence ABC in Part A, Sequence ACB in Part A, Sequence BAC in Part A, Sequence BCA in Part A, Sequence CAB in Part A, Sequence CBA in Part A, Staccato placebo in Part B |
Primary outcome
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 1 in Part A
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
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.
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 4 in Part A
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
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 days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part A.
Percentage of study participants with respiratory treatment-emergent adverse events (TEAEs) in Part A
Time frame: From Baseline (Day 1) to Safety Follow-up period (up to Day 44)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved except for events in users or other persons, which only include events related to investigational devices.
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 1 in Part B
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
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 B.
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 4 in Part B
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
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 days 1 and 4 over each Treatment Period from Baseline to 6 hours postdose in Part B.
Percentage of study participants with respiratory treatment-emergent adverse events (TEAEs) in Part B
Time frame: From Baseline (Day 1) to Safety Follow-up period (up to Day 14)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved except for events in users or other persons, which only include events related to investigational devices.
16 secondary outcomes
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 1 in Part A
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 4 in Part A
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 1 in Part A
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 4 in Part A
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part A
Time frame: From Baseline (Day 1) to Safety Follow-up Period (up to Day 44)
Maximum plasma concentration (Cmax) of Staccato alprazolam in Part A
Time frame: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of Staccato alprazolam in Part A
Time frame: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Area under the plasma concentration-time curve from time 0 to infinity (AUC) of Staccato alprazolam in Part A
Time frame: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 1 in Part B
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Vital Capacity (FVC) to 6 hours postdose on Day 4 in Part B
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 1 in Part B
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 1)
Change from Baseline in Forced Expiratory Volume in 1 second/forced vital capacity (FEV1/FVC) ratio to 6 hours postdose on Day 4 in Part B
Time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 4)
Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part B
Time frame: From Baseline (Day 1) to Safety Follow-up Period (up to Day 14)
Maximum plasma concentration (Cmax) of Staccato alprazolam in Part B
Time frame: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of Staccato alprazolam in Part B
Time frame: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Area under the plasma concentration-time curve from time 0 to infinity (AUC) of Staccato alprazolam in Part B
Time frame: Plasma samples are collected on Day 1 and Day 4 (at Predose, and at 2 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours postdose) and on Day 2 and Day 5 (at 24 hours) of each Treatment Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 41747804Miller SD, LaForce CF, Barlow L, Watanabe S, King A, Burian M, Chanteux H. Pulmonary safety of Staccato alprazolam in healthy participants and participants with mild asthma: Phase 1, randomized, double-blind, placebo-controlled trial. Pulm Pharmacol Ther. 2026 Jun;93:102411. doi: 10.1016/j.pupt.2026.102411. Epub 2026 Feb 24.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alprazolam in people with Healthy Study Participants and Participants With Mild Asthma, run by UCB Biopharma SRL at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 1 in Part A (time frame: From Baseline (predose Day 1) to 6 hours postdose (Day 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.