Clinical Trial: ALX-0171 Safety Study in Adults With Hyperresponsive Airways

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Dos

Brief Summary:

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).


Detailed Summary:
Sponsor: Ablynx

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total number of bronchoconstriction events [ Time Frame: Day 1 to Day 7 ]
  • The frequency of use of β2-agonist for the treatment of study drug/procedure induced bronchoconstriction [ Time Frame: Day 1 to Day 7 ]
  • Safety markers [ Time Frame: From screening to last follow-up visit which will take place between day 35 and day 42 ]
    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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Ablynx

Dates:
Date Received: July 24, 2013
Date Started: August 2013
Date Completion:
Last Updated: January 2, 2014
Last Verified: January 2014