Study Stopped
The study was halted after enrollment of the first cohort because of lack of funding
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
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJune 11, 2013
June 1, 2013
2 months
June 16, 2011
June 10, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects experiencing adverse events
28 days
Secondary Outcomes (2)
Plasma drug concentration
28 days
Urine drug concentration
28 days
Study Arms (2)
AVI-7100
EXPERIMENTALPhosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Placebo
EXPERIMENTALVehicle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit
Madison, Wisconsin, 53704, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Hale, MD
Covance Clinical Research Unit
- STUDY DIRECTOR
Alison Heald, MD
Sarepta Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 20, 2011
Study Start
June 1, 2011
Primary Completion
August 1, 2011
Study Completion
November 1, 2011
Last Updated
June 11, 2013
Record last verified: 2013-06