- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02094365
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
December 22, 2014 updated by: Alios Biopharma Inc.
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
This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo control in the respiratory syncytial virus challenge model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom
- Retroscreen Virology Ltd
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ALS-008176
ALS-008176 drug substance for oral suspension
|
|
Placebo Comparator: vehicle alone
Vehicle alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in viral load measurements.
Time Frame: Baseline to day 12
|
Baseline to day 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hosnieh Fathi, MD, MSc, Retroscreen Virology Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
March 20, 2014
First Submitted That Met QC Criteria
March 20, 2014
First Posted (Estimate)
March 21, 2014
Study Record Updates
Last Update Posted (Estimate)
December 23, 2014
Last Update Submitted That Met QC Criteria
December 22, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALS-8176-502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Janssen Pharmaceutica N.V., BelgiumCompleted
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Janssen Research & Development, LLCCompleted
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Janssen Research & Development, LLCWithdrawnMetapneumovirusNetherlands, United States, France, Taiwan, Korea, Republic of, Australia, Japan, Spain, Malaysia, Russian Federation, Sweden, Poland, Bulgaria, Argentina, Brazil, Ukraine