RSV lower respiratory tract infection MedDRA version: 20.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Ablynx NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is a male or female infant or young child aged 28 days to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subject is known to have significant comorbidities - Subject is known to be HIV-positive (or if the child is <6 months of age, the mother is known to be HIV-positive). - Subject is known to be immunocompromised. - Subject has or is suspected to have an active, clinically relevant concurrent infection - Subject is critically ill and/or is expected to require invasive mechanical ventilation - Subject is currently participating in any other study with investigational drug or has received an investigational drug within 4 weeks or 5 half-lives of the concerned drug (whichever is longer) prior to screening - Subject was previously enrolled in a clinical study of ALX-0171
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for RSV lower respiratory tract infection. ;Secondary Objective: To evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171. ;Primary end point(s): Anti-viral effect, as measured by the time needed for the viral load to drop below the assay quantification limit.;Timepoint(s) of evaluation of this end point: Throughout the in-hospital period, up to Day 14 after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety assessment (assessed by physical examination, AEs, laboratory assessments and vital signs) of different doses of ALX-0171 - Change from baseline in Global Severity Score - Time to clinical response - PK properties of ALX-0171 - Viral load profile over time - Evaluation of serum anti-drug antibodies (ADA) ;Timepoint(s) of evaluation of this end point: Throughout the study, up to Day 28 after randomization | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Estonia, Germany, Hungary, Israel, Latvia, Lithuania, Malaysia, Philippines, Poland, Slovakia, South Africa, Spain, Thailand, United Kingdom
Contacts
Public Contactclinicaltrials@ablynx.com
Ablynx NV
Outcome results
None listed