CompletedPhase 1

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

United States78 participantsStarted 2021-03-09

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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: 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 ar…

What they're measuring

Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) to 6 hours postdose on Day 1 in Part A

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: From Baseline (Day 1) to Safety Follow-up period (up to Day 14)

Trial details

NCT IDNCT04802746

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-22

View on ClinicalTrials.gov More Healthy Study Participants trials