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Completed

NCT Number: NCT02094365

A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model

This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo control in the respiratory syncytial virus challenge model.

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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

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retroscreen Virology Ltd

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 to 45 years, inclusive.
  • In good health with no history of major medical conditions
  • A total body weight ≥ 50 kg and a body mass index (BMI) of > 18kg/m2.

Exclusion criteria

  • Acute or chronic medical illness
  • Positive for Human Immunodeficiency Virus, Hepatitis B or C
  • Nose or nasopharynx abnormalities
  • Abnormal lung function

Treatment and study plan

ALS-008176

Drug

Vehicle

Drug

Primary outcomes

  1. Change in viral load measurements.

    Time frame: Baseline to day 12

Sponsors and collaborators

Lead sponsor

Alios Biopharma Inc.

Industry

Registry information

Official study title

A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered ALS-008176 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 21, 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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