A Study of ALS-008176 in Infants Hospitalized With RSV

Phase 1CompletedNCT02202356

Alios Biopharma Inc.183 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

183

Conditions

Respiratory Syncytial Virus Infections

Interventions

Eligibility

Sex: ALLMax age: 12 Months

Medical Language ↔ Plain English

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

Locations (77)

Outcomes

Primary Outcomes

Adverse Events

Time frame: Baseline through 6 days post-dose

Physical Examinations

Time frame: Baseline through 6 days post-dose

Vital Signs

Time frame: Baseline through 6 days post-dose

12-Lead ECGs

Time frame: Baseline through 6 days post-dose

Clinical Laboratory Results

Time frame: Baseline through 6 days post-dose

Secondary Outcomes

RSV viral RNA concentrations in nasal aspirates

Time frame: Baseline through 6 days post-dose

Emergence of resistance

Changes in RSV polymerase that result in reduced sensitivity to study drug

Time frame: Baseline through 6 days post-dose

Pharmacokinetic parameters, including maximum and minimum drug concentrations

Time frame: Baseline through 6 days post-dose

Pharmacokinetic parameters, including time to maximum concentration and half-life

Time frame: Baseline through 6 days post-dose

Pharmacokinetic parameters, including area under concentration-time curves (AUCs)

Time frame: Baseline through 6 days post-dose

Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)

Data from ClinicalTrials.gov

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NCT02202356 - A Study of ALS-008176 in Infants Hospitalized With RSV | Crick | Crick