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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

CompletedPhase 1, Phase 2

Sponsor: Ablynx, a Sanofi company

Conditions: Respiratory Syncytial Virus Infection

Interventions: ALX-0171, Placebo

Countries: Australia, Belgium, Bulgaria, Estonia, Hungary, Israel, Latvia, Malaysia

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.

Eligibility overview

Sex: ALL

Age: 28 Days to 23 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (59)

Brisbane, Australia
Randwick, Australia
Tasmania, Australia
Westmead, Australia
Antwerp, Belgium
Antwerp, Belgium
Brussels, Belgium
Brussels, Belgium
Ghent, Belgium
Leuven, Belgium
Kozloduy, Bulgaria
Pleven, Bulgaria
Rousse, Bulgaria
Sevlievo, Bulgaria
Tartu, Estonia
Budapest, Hungary
Budapest, Hungary
Budapest, Hungary
Budapest, Hungary
Szeged, Hungary
Beersheba, Israel
Haifa, Israel
Petah Tikva, Israel
Daugavpils, Latvia
Riga, Latvia
Valmiera, Latvia
Ipoh, Malaysia
Kuala Lumpur, Malaysia
Negeri Sembilan, Malaysia
Pulau Pinang, Malaysia
+ 29 more on CT.gov