Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)

Respiratory Syncytial Virus Infections Clinical Trial

— Challenge  

Official title:

Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV-A Memphis 37b Strain)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756482
• Other study ID #: GS-US-218-0103
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2012
• Last updated: August 3, 2015
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male or female

• Between 18 to 45 years old

• Body Mass Index of 18 to 33 kg/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, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• GS-5806
GS-5806, powder for oral solution
• Placebo

Locations

Country	Name	City	State
United Kingdom	Retroscreen Virology	London

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load measurements.	Area under the curve for viral load as measured by qRT-PCR assay from the first viral load measurement post initial dose of GS-5806 or placebo through day 12.	Post initial dose of GS-5806/placebo to Day 12	Yes
Secondary	Change of baseline symptoms	Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12	Innoculation through Day 12	Yes