Safety Study of Single Administration Intravenous Treatment for Influenza

This study has been terminated.
(The study was halted after enrollment of the first cohort because of lack of funding)
Sponsor:
Information provided by (Responsible Party):
Sarepta Therapeutics
ClinicalTrials.gov Identifier:
NCT01375985
First received: June 16, 2011
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Influenza
Drug: AVI-7100
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sarepta Therapeutics:

Primary Outcome Measures:
  • Number of subjects experiencing adverse events [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma drug concentration [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Urine drug concentration [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVI-7100
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Drug: AVI-7100
Single intravenous administration
Experimental: Placebo
Vehicle
Drug: Placebo
Single intravenous administration

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375985

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

No publications provided

Responsible Party: Sarepta Therapeutics
ClinicalTrials.gov Identifier: NCT01375985     History of Changes
Other Study ID Numbers: 7100-us-101
Study First Received: June 16, 2011
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014