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Safety Study of Single Administration Intravenous Treatment for Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01375985
Recruitment Status : Terminated (The study was halted after enrollment of the first cohort because of lack of funding)
First Posted : June 20, 2011
Last Update Posted : June 11, 2013
Information provided by (Responsible Party):
Sarepta Therapeutics

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: AVI-7100 Drug: Placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects
Study Start Date : June 2011
Primary Completion Date : August 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AVI-7100
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Drug: AVI-7100
Single intravenous administration
Experimental: Placebo
Drug: Placebo
Single intravenous administration

Primary Outcome Measures :
  1. Number of subjects experiencing adverse events [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Plasma drug concentration [ Time Frame: 28 days ]
  2. Urine drug concentration [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01375985

United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Sarepta Therapeutics
Principal Investigator: Christine Hale, MD Covance Clinical Research Unit
Study Director: Alison Heald, MD Sarepta Therapeutics

Responsible Party: Sarepta Therapeutics Identifier: NCT01375985     History of Changes
Other Study ID Numbers: 7100-us-101
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases