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

  • STATUS
    Recruiting
  • days left to enroll
    79
  • participants needed
    78
  • sponsor
    UCB Biopharma SRL
Updated on 19 June 2021

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

Details
Condition Healthy Study Participants, Participants With Mild Asthma
Treatment Placebo, Alprazolam
Clinical Study IdentifierNCT04802746
SponsorUCB Biopharma SRL
Last Modified on19 June 2021

Eligibility

Yes No Not Sure

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 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 medical history of asthma beginning at least 6 months prior to the Screening Visit and evidenced by asthma symptoms (wheezing, shortness of breath, cough and/or chest tightness) and need for bronchodilators for symptom relief
Participant has mild asthma controlled with as needed short-acting beta2-agonist (SABA)s and/or maintenance treatment with daily low dose inhaled corticosteroids (ICS) or daily leukotriene receptor antagonists (at least 4 weeks prior to 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%. A washout period of at least 6 hours after the last SABA intake is required before performing spirometric assessments at Screening. 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 not experienced asthma exacerbations (requiring use of oral or injectable corticosteroids) or lower respiratory tract infections in the past 4 weeks before investigational medicinal product (IMP) administration

Exclusion Criteria

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 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
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 30g 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)
Part A: Healthy study participants
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 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 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 AE. This does not include oral contraceptives not exceeding 30g ethinyl estradiol or postmenopausal hormone replacement therapy or implants, patches, IUDs/IUSs delivering progesterone (for female study participants), non-sedating antihistamines, and recommended treatments for mild asthma including SABAs, low-dose ICS, and leukotriene receptor antagonists
Participant has a history of or current respiratory disease characterized by airway hyperresponsiveness excluding asthma (eg, COPD, pulmonary fibrosis, obstructive sleep apnea, pneumothorax, etc)
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