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

Gilead Sciences140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Respiratory Syncytial Virus Infections

Interventions

GS-5806DRUG

GS-5806, powder for oral solution

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Retroscreen Virology

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Post initial dose of GS-5806/placebo to Day 12

Secondary Outcomes

Change of baseline symptoms

Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12

Time frame: Innoculation through Day 12

Data from ClinicalTrials.gov

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