Back to resultsA Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
ALS-008176
vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus Infections
Eligibility 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
Sites / Locations
- Retroscreen Virology Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALS-008176
vehicle alone
Arm Description
ALS-008176 drug substance for oral suspension
Vehicle alone
Outcomes
Primary Outcome Measures
Change in viral load measurements.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02094365
Brief Title
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alios Biopharma Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALS-008176
Arm Type
Experimental
Arm Description
ALS-008176 drug substance for oral suspension
Arm Title
vehicle alone
Arm Type
Placebo Comparator
Arm Description
Vehicle alone
Intervention Type
Drug
Intervention Name(s)
ALS-008176
Intervention Type
Drug
Intervention Name(s)
vehicle
Primary Outcome Measure Information:
Title
Change in viral load measurements.
Time Frame
Baseline to day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hosnieh Fathi, MD, MSc
Organizational Affiliation
Retroscreen Virology Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retroscreen Virology Ltd
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26580997
Citation
DeVincenzo JP, McClure MW, Symons JA, Fathi H, Westland C, Chanda S, Lambkin-Williams R, Smith P, Zhang Q, Beigelman L, Blatt LM, Fry J. Activity of Oral ALS-008176 in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2015 Nov 19;373(21):2048-58. doi: 10.1056/NEJMoa1413275.
Results Reference
derived
Learn more about this trial
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
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