NCT02989194

Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A

A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Visterra, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza.

Detailed description

Subjects will be admitted to an infusion unit for drug administration and observation following infusion. The study is designed to compare an infusion of a single high or low IV dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	VIS410 low dose	Single intravenous fixed low dose of VIS410
DRUG	VIS410 high dose	Single intravenous fixed high dose of VIS410
DRUG	Placebo	Single intravenous infusion of placebo

Timeline

• Start date: 2017-01-06
• Primary completion: 2017-10-27
• Completion: 2017-10-27
• First posted: 2016-12-12
• Last updated: 2022-08-15
• Results posted: 2022-08-15

Locations

54 sites across 7 countries: United States, Bulgaria, Estonia, Latvia, Serbia, South Africa, Ukraine