Respiratory Syncytial Virus Lower Respiratory Tract Infection MedDRA version: 18.0 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: 1. Subject is a male or female infant or toddler aged 5 months to 37 weeks. 9. Parent(s)/legal guardian(s) are able and willing to provide written informed consent. 10. The subject and parent(s)/legal guardian(s) are able and willing to comply with the study protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 53 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has history of wheezing (i.e., >3 previous episodes of wheezing), as reported by the parent(s)/legal guardian(s), or according to the Investigator’s judgement at screening. 2. Subject is known to have significant comorbidities, including gastro-oesophageal reflux disease, genetic disorders (e.g., trisomy 21, cytic fibrosis), cardiopulmonary diseases (e.g., haemodynamically significant congenital heart disease, or bronchopulmonary dysplasia), any hereditary or acquired metabolic (bone) diseases, haematological or other malignancy, or is known to be human immunodeficiency virus (HIV) positive. 3. Subject is known to be immunocompromised. 4. Subject has any presence of active severe atopic dermatitis requiring daily use of topical anti-inflamatory (corticosteriod or equivalent). 5. Subject has any physician-confirmed food allergy. 6. Subject is suspected of having a clinically relevant infection other than RSV. 7. Subject received mechanical ventilation or long-term respiratory support in past 4 weeks prior to screnning. 8. Subject has significant oral and/or maxillofacial malformations. 9. Subject is critically ill and/or is expected to require invasive mechanical ventilation or non-invasive respiratory support (e.g., continuous or bi-level positive airway pressure, or high flow humidified nasal oxygen) within 24 hours (according to the Investigator’s judgement at screening), with the exception of O2 supplementation via nasal cannula, simple face mask, or headbox. 10. Subject has received 1 or more doses of palivizumab at any time prior to screening, or has received treatment with any antiviral therapy for RSV (e.g., ribavirin or i.v. immunoglobulin) within 1 month prior to screening. Subjects planned to receive palivizumab treatment or other RSV prophylaxis should not be included in the study. 11. Subject is being treated with corticosteroids and requires continued corticosteriod therapy. 12. Subject is being treated with antibiotics and needs continued antibiotic therapy. Note that subjects receiving antibiotics at screening will not be excluded if the antibiotics can be safely stopped according to the Investigator’s judgement. The initiation of antibiotic therapy during the study is allowed. 13. Subject is currently participating in any investigational study, or has previously participated in study ALX0171-C104.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of multiple doses of ALX-0171;Primary end point(s): Safety: Treatment emergent AEs, clinical laboratory test results (clinical chemistry and haematology), physical examination results including lung auscultation, and heart rate and SPO2 levels.;Timepoint(s) of evaluation of this end point: day 0 to day 14 ; Secondary Objective: To evaluate the clinical effect of ALX-0171. To explore the pharmacodynamics of ALX-0171 To explore the systemic pharmacokinetics of ALX-0171 To explore the immunogenicity of ALX-0171 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: day 0 to day 14 ; Secondary end point(s): 1) Clinical activity: feeding, respiratory rate, wheezing, crackles/crepitations, coughing, respiratory muscle retractions, general appearance 2) Exploratory pharmacokinetics: ALX-0171 in serum 3) Exploratory pharmacodynamics: viral load (nasal swabs), exploratory biomarkers in serum 4) Exploratory immunogenicity: ADA in serum | — |
Countries
Australia, Belgium, Bulgaria, Estonia, Hungary, Israel, Latvia, Malaysia, Philippines, Poland, Slovakia, Spain, Thailand, United Kingdom
Contacts
Public Contactclinicaltrials@ablynx.com
Ablynx NV
Outcome results
None listed