Safety Study of Single Administration Intravenous Treatment for Influenza

NCT ID: NCT01375985

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-11-30

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AVI-7100

Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)

Group Type: EXPERIMENTAL

AVI-7100

Intervention Type: DRUG

Single intravenous administration

Placebo

Vehicle

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Single intravenous administration

Interventions

AVI-7100

Single intravenous administration

Intervention Type: DRUG

Placebo

Single intravenous administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sarepta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Hale, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit

Alison Heald, MD

Role: STUDY_DIRECTOR

Sarepta Therapeutics, Inc.

Locations

Covance Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

7100-us-101

Identifier Type: -

Identifier Source: org_study_id