NCT02623322

A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, Administered as Monotherapy for the Treatment of Acute Uncomplicated Seasonal Influenza A Infection in Otherwise Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.

Conditions

• Influenza A

Interventions

Type	Name	Description
DRUG	MHAA4549A	MHAA4549A will be administered as a single dose by IV administration.
DRUG	Placebo	Placebo will be administered as a single dose by IV administration.

Timeline

• Start date: 2016-10-12
• Primary completion: 2017-11-13
• Completion: 2017-11-13
• First posted: 2015-12-07
• Last updated: 2019-01-08
• Results posted: 2019-01-08

Locations

80 sites across 7 countries: United States, Canada, New Zealand, South Africa, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study