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OpenTrials
Completed

NCT Number: NCT01756482

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

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

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retroscreen Virology

London, E12AX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-5806

Drug

GS-5806, powder for oral solution

Placebo

Drug

Primary outcomes

  1. Change in viral load measurements.

    Time frame: 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 outcomes

  1. Change of baseline symptoms

    Time frame: Innoculation through Day 12

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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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)

Acronym: Challenge

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 27, 2012
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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