A Study of ALS-008176 in Infants Hospitalized With RSV

Alios Biopharma

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: ALS-008176; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02202356

ALS-8176-503

2013-005104-33 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

Enrollment: 183 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or <28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 4 patient groups, including a placebo group

ALS-008176 Single Dose

Experimental group

Description:

Single dose of ALS-008176 administered orally as a suspension

Treatment:

Drug: ALS-008176

Placebo Single Dose

Placebo Comparator group

Description:

Single dose of placebo administered orally as a suspension

Treatment:

Drug: Placebo

ALS-008176 Multiple Doses

Experimental group

Description:

Multiple doses of ALS-008176 administered orally as a suspension

Treatment:

Drug: ALS-008176

Placebo Multiple Doses

Placebo Comparator group

Description:

Multiple doses of placebo administered orally as a suspension

Treatment:

Drug: Placebo