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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02309320

Enrollment

Registered

2014-12-05

Start date

2014-12-31

Completion date

2016-02-29

Last updated

2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infection

Brief 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.

Interventions

BIOLOGICALALX-0171

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

28 Days to 23 Months

Healthy volunteers

Inclusion criteria

1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection) 2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV 3. Subject has a positive RSV diagnostic test 4. Others as defined in the protocol

Exclusion criteria

1. Subject has history of wheezing 2. Subject is known to have significant comorbidities 3. Subject is known to be immunocompromised 4. Subject is suspected of having a clinically relevant infection other than RSV 5. Others as defined in the protocol

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination	1 day before first dose to 14 days after first dose

Secondary

Measure	Time frame
Clinical activity as measured by the evaluation of the clinical response of the subjects	1 day before first dose to 14 days after first dose
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum	Day 3
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum	1 day before first dose to 14 days after first dose
Immunogenicity as measured by the concentration of anti-drug antibodies in serum	1 day before first dose to 14 days after first dose

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026