Safety Study of Single Administration Intravenous Treatment for Influenza

Phase 1

Terminated

• Conditions: Influenza
• Interventions: Drug: AVI-7100; Drug: Placebo

• Registration Number: NCT01375985
• Lead Sponsor: Sarepta Therapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2011-08
• Study Completion: 2011-11
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Male or female and between the ages of 18 and 50 years in good general health
• Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
• Volunteers must be willing to undergo a urine screen for drugs of abuse

Exclusion Criteria

• Pregnancy or breastfeeding.
• Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
• Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVI-7100	AVI-7100	Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Placebo	Placebo	Vehicle

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing adverse events	28 days

Secondary Outcome Measures

Name	Time	Method
Plasma drug concentration	28 days
Urine drug concentration	28 days

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States