A Study of ALS-008176 in Infants Hospitalized With RSV

A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222986

Enrollment

Registered

2015-10-14

Start date

2015-10-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

investigational material(s) Generic name etc : ALS-008176 INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026