ALX-0171 Safety Study in Adults With Hyperresponsive Airways
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Single-centre, Open Label Study to Evaluate the Potential Occurrence, Reversibility and Prevention of Bronchoconstriction as Individual Response to Escalating Doses Followed by Repeated Doses of ALX-0171, Administered by Oral Inhalation to Adults With Hyperresponsive Airways|
- Number of subjects reacting with bronchoconstriction to treatment (ALX- 0171 placebo or ALX-0171 verum) with one or more drops in forced expiratory volume in one second (FEV1) within a period of 8h post-inhalation [ Time Frame: Within a period of 8 hours post-inhalation ] [ Designated as safety issue: Yes ]
- Total number of bronchoconstriction events [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: Yes ]
- The frequency of use of β2-agonist for the treatment of study drug/procedure induced bronchoconstriction [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: Yes ]
- Safety markers [ Time Frame: From screening to last follow-up visit which will take place between day 35 and day 42 ] [ Designated as safety issue: Yes ]between others: physical examination, vital signs, 12-lead ECG, clinical laboratory (hematology and serum chemistry), urine analysis, serology, adverse events
- Pharmacokinetic parameters: plasma concentrations of ALX-0171 [ Time Frame: Day 1 to Day 8 ] [ Designated as safety issue: No ]
- Immunogenicity: presence of anti-drug antibodies (ADA) in serum, presence of ADA in sputum [ Time Frame: From screening to last follow-up visit which will take place between day 35 and day 42 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: ALX-0171 Oral inhalation||
Escalating dose of ALX-0171 during maximum 3 consecutive days: from 2.1 mg to maximum 200 mg per inhaled dose followed by daily dose of 70 mg, 140 mg or 200 mg per dose for maximum 4 consecutive days