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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094365
• Other study ID #: ALS-8176-502
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2014
• Last updated: December 22, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: Alios Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALS-008176

• vehicle

Locations

Country	Name	City	State
United Kingdom	Retroscreen Virology Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Alios Biopharma Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load measurements.		Baseline to day 12	No