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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

NCT02309320 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-01-10

No results posted yet for this study

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

BIOLOGICAL

ALX-0171

OTHER

Placebo

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Ablynx Clinical Department · Ablynx, a Sanofi company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
23 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Australia
  • Belgium
  • Bulgaria
  • Estonia
  • Hungary
  • Israel
  • Latvia
  • Malaysia
  • Philippines
  • Poland
  • Slovakia
  • Spain
  • Thailand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02309320 on ClinicalTrials.gov