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ALX-0171 Safety Study in Adults With Hyperresponsive Airways

Respiratory Syncytial Virus Infection Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
  • Virus Diseases
Clinical Trial Details
NCT number NCT01909843
Study type Interventional
Source Ablynx
Contact
Status Completed
Phase Phase 1
Start date July 2013
Completion date December 2013
View Details
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