NCT02309320

A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

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: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 28 Days – 23 Months
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to investigate the safety and tolerability of ALX-0171. The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.

Conditions

• Respiratory Syncytial Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	ALX-0171
OTHER	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-12-05
• Last updated: 2019-01-10

Locations

59 sites across 14 countries: Australia, Belgium, Bulgaria, Estonia, Hungary, Israel, Latvia, Malaysia, Philippines, Poland, Slovakia, Spain, Thailand, United Kingdom