NCT01353027

Brief Summary

The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

May 10, 2011

Last Update Submit

March 27, 2012

Conditions

Ebola Hemorrhagic Fever

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    The frequency and severity of adverse events will be monitored through 28 days post administration.

    28 Days

Secondary Outcomes (2)

  • Drug concentration in plasma

    28 days

  • Drug concentration in urine

    28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

AVI-6002

EXPERIMENTAL

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

Drug: AVI-6002

Interventions

PlaceboDRUG

Normal saline

Placebo
AVI-6002DRUG

Single intravenous administration

AVI-6002

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • William B Smith, MD

    New Orleans Center for Clinical Research-Knoxville

    PRINCIPAL INVESTIGATOR

  • Alison Heald, MD

    Sarepta Therapeutics, Inc.

    STUDY DIRECTOR

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

May 10, 2011

First Posted

May 12, 2011

Study Start

May 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

US(1)