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Completed

NCT Number: 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

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.

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Key information

Conditions

Respiratory Syncytial Virus Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

28 day–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigator Site 4, Brisbane, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
  • Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
  • Subject has a positive RSV diagnostic test
  • Others as defined in the protocol

Exclusion criteria

  • Subject has history of wheezing
  • Subject is known to have significant comorbidities
  • Subject is known to be immunocompromised
  • Subject is suspected of having a clinically relevant infection other than RSV
  • Others as defined in the protocol

Treatment and study plan

ALX-0171

Biological

Placebo

Other

Primary outcomes

  1. Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination

    Time frame: 1 day before first dose to 14 days after first dose

Secondary outcomes

  1. Clinical activity as measured by the evaluation of the clinical response of the subjects

    Time frame: 1 day before first dose to 14 days after first dose

  2. Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum

    Time frame: Day 3

  3. Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum

    Time frame: 1 day before first dose to 14 days after first dose

  4. Immunogenicity as measured by the concentration of anti-drug antibodies in serum

    Time frame: 1 day before first dose to 14 days after first dose

Sponsors and collaborators

Lead sponsor

Ablynx, a Sanofi company

Industry

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2014
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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