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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02094365
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: ALS-008176 Drug: vehicle Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2014
Primary Completion Date : June 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ALS-008176
ALS-008176 drug substance for oral suspension
Drug: ALS-008176
Placebo Comparator: vehicle alone
Vehicle alone
Drug: vehicle


Outcome Measures

Primary Outcome Measures :
  1. Change in viral load measurements. [ Time Frame: Baseline to day 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094365


Locations
United Kingdom
Retroscreen Virology Ltd
London, United Kingdom
Sponsors and Collaborators
Alios Biopharma Inc.
Investigators
Principal Investigator: Hosnieh Fathi, MD, MSc Retroscreen Virology Ltd.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT02094365     History of Changes
Other Study ID Numbers: ALS-8176-502
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Infection
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections