NCT01375985

Safety Study of Single Administration Intravenous Treatment for Influenza

A Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sarepta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-7100, a candidate treatment for influenza.

Detailed description

Influenza A, a member of the Orthomyxoviridae family, is composed of a negative-sense,single-stranded and segmented ribonucleic acid (RNA) genome. An urgent need exists for new forms of treatment for influenza A based on (a) the known propensity of this virus to undergo both continuous low-level antigenic drift and less frequent but unpredictable major antigenic shift leading to pandemic disease, (b) the clear failure of vaccination, even when strains are reasonably matched, to prevent influenza-related illness in a significant proportion of vaccine recipients, and (c) the increased frequency of resistance to approved forms of therapy for influenza (eg, the adamantane derivatives and, more recently, the NA inhibitor, oseltamivir). AVI-7100 is an experimental phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). AVI-7100 specifically targets viral messenger RNA sequences. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-7100 in healthy human subjects.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	AVI-7100	Single intravenous administration
DRUG	Placebo	Single intravenous administration

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-08-01
• Completion: 2011-11-01
• First posted: 2011-06-20
• Last updated: 2013-06-11

Locations

1 site across 1 country: United States