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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01756482

Acronym

Challenge

Enrollment

140

Registered

2012-12-27

Start date

2012-11-30

Completion date

2013-06-30

Last updated

2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory, Syncytial, Virus, Infections, RSV

Brief summary

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

Interventions

DRUGGS-5806

GS-5806, powder for oral solution

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Change of baseline symptoms	Innoculation through Day 12	Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026