ALX-0171 Safety Study in Adults With Hyperresponsive Airways

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).

Timeline

Start

2013-07

Primary completion

2013-12

Completion

2013-12

Drugs

Indications