NCT02468115

Influenza Challenge Study of VIS410 in Healthy Volunteers

A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Antiviral Activity of a Single Intravenous Dose of VIS410 in Healthy Subjects After a Viral Inoculation With Influenza A (H1N1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Visterra, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects after inoculation with influenza A virus (H1N1).

Detailed description

This is a phase 2a randomized, double-blind, placebo-controlled study to be conducted in healthy volunteers. The study is designed to compare an infusion of a single dose of VIS410 against placebo. Eligible volunteers will be admitted to the clinical center and will receive a single intranasal administration of influenza A (H1N1). One day (24h) after inoculation, subjects will receive a single administration of VIS410 or placebo. Subjects will be confined in the clinical center for 10 days after virus administration. Assessment of safety will be determined from vital sign measurements, physical examinations, hematology, chemistry and urinalysis laboratory testing, 12-lead electrocardiograms (ECGs), pulmonary function, use of concomitant medications, and review of adverse events (AEs) should they occur. During confinement in the clinical center a symptom score card of influenza symptoms will be completed three times a day; nasopharyngeal swabs will be obtained three times a day and assayed for the presence of influenza virus and VIS410 concentration; serum samples will be assayed for VIS410 and the presence of cytokines. Upon release from the clinical center subjects will return for follow-up visits on days 14, 28 and either 56 or 84.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	VIS410	Single fixed IV dose of VIS410
DRUG	Placebo	Single IV dose of placebo

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-06-10
• Last updated: 2016-04-05

Locations

1 site across 1 country: Belgium