Trial record 2 of 18 for:    Open Studies | "Respiratory Syncytial Virus Infections"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Alios Biopharma Inc.
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.
ClinicalTrials.gov Identifier:
NCT02094365
First received: March 20, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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 Intervention Phase
Respiratory Syncytial Virus Infections
Drug: ALS-008176
Drug: vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Alios Biopharma Inc.:

Primary Outcome Measures:
  • Change in viral load measurements. [ Time Frame: Baseline to day 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: March 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALS-008176
ALS-008176 drug substance for oral suspension
Drug: ALS-008176
Placebo Comparator: vehicle alone
Vehicle alone
Drug: vehicle

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094365

Locations
United Kingdom
Retroscreen Virology Ltd Recruiting
London, United Kingdom
Contact: Temi Giwa, MD, MSci    787 508 4287      
Principal Investigator: Hosnieh Fathi, MD, MSc         
Sponsors and Collaborators
Alios Biopharma Inc.
Investigators
Principal Investigator: Hosnieh Fathi, MD, MSc Retroscreen Virology Ltd.
  More Information

No publications provided

Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT02094365     History of Changes
Other Study ID Numbers: ALS-8176-502
Study First Received: March 20, 2014
Last Updated: March 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 26, 2014