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About
This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways.
This phase I study is an exploratory study and serves to evaluate the occurrence and reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label trial with a sequential administration regimen of placebo and verum in all planned study subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (= formulation buffer) followed by escalating doses of ALX-0171 verum.
Eventually a second administration of ALX-0171 placebo may take place at the end of the study (as defined per protocol).
Enrollment
Sex
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Inclusion criteria
Adult male and female subjects aged 18-60 years (both included).
Subjects must demonstrate a PC20 (concentration of the agonist in the inhaled substance leading to a fall in FEV1 of ≥20.0% of personal best at same visit) response to methacholine (MCh) concentrations of > 1 mg/mL and ≤ 8 mg/mL at screening.
Subjects not on concomitant treatments except for
Screening forced expiratory volume (FEV1) value of > 60.0% of the predicted normal value after a wash-out of respiratory medication as listed in the protocol.
Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure.
Body weight according to a Body Mass Index ≥ 18.5 and ≤ 29.0 kg/m².
Non-smokers or ex-smokers who have stopped smoking for at least 1 year prior to start of the clinical study. No history of smoking more than 10 pack years.
Ability to inhale in an appropriate manner.
Female subjects of childbearing potential and male subjects must agree to use appropriate methods of contraception as specified in the protocol.
Exclusion criteria
Primary purpose
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Interventional model
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24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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