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

Phase 2

Completed

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: GS-5806; Drug: Placebo

• Registration Number: NCT01756482
• Lead Sponsor: Gilead Sciences

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-26
• Study First Posted: 2012-12-27
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Disposition First Submitted: 2014-01-02
• Disposition First Submitted QC: 2014-01-02
• Disposition First Posted: 2014-02-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Healthy male or female
• Between 18 to 45 years old
• Body Mass Index of 18 to 33 kg/m2

Read More

Exclusion Criteria

• Acute or chronic medical illness
• Positive for Human Immunodeficiency Virus, Hepatitis B or C
• Nose or nasopharynx abnormalities
• Abnormal lung function

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GS-5806	GS-5806	GS-5806, powder for oral solution
Sugar powder for oral solution in juice	Placebo	Sugar powder for oral solution

Primary Outcome Measures

Name	Time	Method
Change in viral load measurements.	Post initial dose of GS-5806/placebo to Day 12	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.

Secondary Outcome Measures

Name	Time	Method
Change of baseline symptoms	Innoculation through Day 12	Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12

Trial Locations

Locations (1)

Retroscreen Virology; 🇬🇧 London, United Kingdom