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

Phase 2

Completed

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: ALS-008176; Drug: vehicle

• Registration Number: NCT02094365
• Lead Sponsor: Alios Biopharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALS-008176	ALS-008176	ALS-008176 drug substance for oral suspension
vehicle alone	vehicle	Vehicle alone

Primary Outcome Measures

Name	Time	Method
Change in viral load measurements.	Baseline to day 12

Trial Locations

Locations (1)

Retroscreen Virology Ltd; 🇬🇧 London, United Kingdom