Clinical trial 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
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Virus Infection
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 53
Sex: ALL
Minimum age (years): 28
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
timeFrame: 1 day before first dose to 14 days after first dose
Secondary outcomes:
measure: Clinical activity as measured by the evaluation of the clinical response of the subjects
timeFrame: 1 day before first dose to 14 days after first dose
measure: Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
timeFrame: Day 3
measure: Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
timeFrame: 1 day before first dose to 14 days after first dose
measure: Immunogenicity as measured by the concentration of anti-drug antibodies in serum
timeFrame: 1 day before first dose to 14 days after first dose
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Investigator Site 4
city: Randwick
country: Australia
facility: Investigator Site 2
city: Tasmania
country: Australia
facility: Investigator Site 3
city: Westmead
country: Australia
facility: Investigator Site 1
city: Antwerp
country: Belgium
facility: Investigator Site 1
city: Antwerp
country: Belgium
facility: Investigator Site 6
city: Brussels
country: Belgium
facility: Investigator Site 4
city: Brussels
country: Belgium
facility: Investigator Site 5
city: Ghent
country: Belgium
facility: Investigator Site 2
city: Leuven
country: Belgium
facility: Investigator Site 3
city: Kozloduy
country: Bulgaria
facility: Investigator Site 4
city: Pleven
country: Bulgaria
facility: Investigator Site 1
city: Ruse
country: Bulgaria
facility: Investigator Site 2
city: Sevlievo
country: Bulgaria
facility: Investigator Site 3
city: Tartu
country: Estonia
facility: Investigator Site
city: Budapest
country: Hungary
facility: Investigator Site 1
city: Budapest
country: Hungary
facility: Investigators Site 3
city: Budapest
country: Hungary
facility: Investigator Site 4
city: Budapest
country: Hungary
facility: Investigator Site 5
city: Szeged
country: Hungary
facility: Investigator Site 2
city: Beer Sheva
country: Israel
facility: Investigator Site 3
city: Haifa
country: Israel
facility: Investigator Site 2
city: Petah-Tikva
country: Israel
facility: Investigator Site 1
city: Daugavpils
country: Latvia
facility: Investigator Site 3
city: Riga
country: Latvia
facility: Investigator Site 2
city: Valmiera
country: Latvia
facility: Investigator Site 1
city: Ipoh
country: Malaysia
facility: Investigator Site 2
city: Kuala Lumpur
country: Malaysia
facility: Investigator Site 1
city: Negeri Sembilan
country: Malaysia
facility: Investigator Site 3
city: Pulau Pinang
country: Malaysia
facility: Investigator Site 4
city: Manila
country: Philippines
facility: Investigator Site
city: Muntinlupa
country: Philippines
facility: Investigator Site
city: Quezon City
country: Philippines
facility: Investigator Site
city: Bydgoszcz
country: Poland
facility: Investigator Site 3
city: Lodz
country: Poland
facility: Investigator Site 2
city: Trzebnica
country: Poland
facility: Investigator Site 1
city: Banska Bystrica
country: Slovakia
facility: Investigator Site 5
city: Bratislava
country: Slovakia
facility: Investigator Site 3
city: Kosice
country: Slovakia
facility: Investigator Site 2
city: Levice
country: Slovakia
facility: Investigator Site 6
city: Liptovsky Mikulas
country: Slovakia
facility: Investigator Site 7
city: Martin
country: Slovakia
facility: Investigator Site 1
city: Poprad
country: Slovakia
facility: Investigator Site 4
city: Barcelona
country: Spain
facility: Investigator Site 5
city: Barcelona
country: Spain
facility: Investigator Site 2
city: Girona
country: Spain
facility: Investigator Site 4
city: Madrid
country: Spain
facility: Investigator Site 3
city: Malaga
country: Spain
facility: Investigator Site 7
city: Murcia
country: Spain
facility: Investigator Site 6
city: Santiago de Compostela
country: Spain
facility: Investigator Site 1
city: Sevilla
country: Spain
facility: Investigator Site 8
city: Chiang Mai
country: Thailand
facility: Investigator Site 2
city: Khon Kaen
country: Thailand
facility: Investigator Site
city: City Of Edinburgh
country: United Kingdom
facility: Investigator Site 2
city: Kent
country: United Kingdom
facility: Investigator Site 4
city: Liverpool
country: United Kingdom
facility: Investigator Site 5
city: Nottingham
country: United Kingdom
facility: Investigator Site 6
city: Oxford
country: United Kingdom
facility: Investigator Site 1
city: Tooting
country: United Kingdom
facility: Investigator Site 3
Study officials:
affiliation: Ablynx, a Sanofi company
name: Ablynx Clinical Department
role: STUDY_DIRECTOR
References: