A Study of ALS-008176 in Infants Hospitalized With RSV

Phase 1

• Conditions: Respiratory Syncytial Virus Infections

• Registration Number: JPRN-jRCT2080222986
• Lead Sponsor: Janssen Pharmaceutical K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Male or female subjects, 1-12 months old, hospitalized with RSV infection, in otherwise good health

Exclusion Criteria

Prematurity
Receiving invasive endotracheal mechanical ventilation
Poorly functioning gastrointestinal tract
Anticipated to be discharged from the hospital in <24 hours from the time of randomization
Prior exposure to palivizumab

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures: safety data, including adverse events, physical examinations, vital signs, 12-lead ECGs and clinical laboratory results

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures: RSV viral RNA concentration in nasal aspirates, emergence of resistance, changes in RSV polymerase that result in reduced sensitivity to study drug, measures of pharmacokinetic parameters including Cmax, Cmin, tmax, t1/2, area under concentration-time curves (AUCs)