NCT01353040

Brief Summary

The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg virus.

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 2011

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

April 22, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

April 22, 2011

Last Update Submit

May 4, 2012

Conditions

Marburg Hemorrhagic Fever

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-6003

EXPERIMENTAL

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

Drug: AVI-6003

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Placebo

Interventions

AVI-6003DRUG

Single intravenous administration

AVI-6003
PlaceboDRUG

Single intravenous administration

Placebo

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)

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Marburg Virus Disease

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales InfectionsMonkey DiseasesPrimate DiseasesAnimal Diseases

Study Officials

  • Alison Heald, MD

    Sarepta Therapeutics, Inc.

    STUDY DIRECTOR

  • Apinya B Vutikullird, MD

    West Coast Clinical Trials

    PRINCIPAL INVESTIGATOR

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

April 22, 2011

First Posted

May 12, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

US(1)