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A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care.

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Trial Profile

A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care.

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Mar 2023

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At a glance

  • Drugs Gontivimab (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Proof of concept
  • Sponsors Ablynx

Most Recent Events

  • 03 May 2016 Top-line results published in an Ablynx media release.
  • 03 May 2016 Top-line results published in an Ablynx media release.
  • 03 May 2016 Top-line results of ALX-0171 inhaled using Vectura's FOX device in hospitalised infants (n=53) published in the Vectura media release.

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