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Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

NCT02979431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-10-18

Study results available
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Summary

The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.

Conditions

  • Respiratory Syncytial Virus Lower Respiratory Tract Infection

Interventions

BIOLOGICAL

ALX-0171 3.0 mg/kg

BIOLOGICAL

ALX-0171 6.0 mg/kg

BIOLOGICAL

ALX-0171 9.0 mg/kg

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
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-11
Primary Completion
2018-05-25
Completion
2018-05-25

Countries

  • Belgium
  • Bulgaria
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Israel
  • Latvia
  • Malaysia
  • Philippines
  • Poland
  • Slovakia
  • Spain
  • Thailand

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 NCT02979431 on ClinicalTrials.gov