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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: GS-5806; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756482

GS-US-218-0103

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

GS-5806

Experimental group

Description:

GS-5806, powder for oral solution

Treatment:

Drug: GS-5806

Sugar powder for oral solution in juice

Placebo Comparator group

Description:

Sugar powder for oral solution

Treatment:

Drug: Placebo