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NCT Number: NCT02202356

A Study of ALS-008176 in Infants Hospitalized With RSV

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)

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Canberra Hospital, Canberra, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALS-008176

Drug

Placebo

Drug

Primary outcomes

  1. Adverse Events

    Time frame: Baseline through 6 days post-dose

  2. Physical Examinations

    Time frame: Baseline through 6 days post-dose

  3. Vital Signs

    Time frame: Baseline through 6 days post-dose

  4. 12-Lead ECGs

    Time frame: Baseline through 6 days post-dose

  5. Clinical Laboratory Results

    Time frame: Baseline through 6 days post-dose

Secondary outcomes

  1. RSV viral RNA concentrations in nasal aspirates

    Time frame: Baseline through 6 days post-dose

  2. Emergence of resistance

    Time frame: Baseline through 6 days post-dose

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

  3. Pharmacokinetic parameters, including maximum and minimum drug concentrations

    Time frame: Baseline through 6 days post-dose

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

    Time frame: Baseline through 6 days post-dose

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

    Time frame: Baseline through 6 days post-dose

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

    Time frame: Baseline through 6 days post-dose

Sponsors and collaborators

Lead sponsor

Alios Biopharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2014
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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