Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus

A Phase I Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6002 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01353027

Enrollment

Registered

2011-05-12

Start date

2010-05-31

Completion date

2011-11-30

Last updated

2012-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola Hemorrhagic Fever

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.

Detailed description

Ebola hemorrhagic fever (EHF) is a rare human disease caused by Ebola Virus (EBOV), a filamentous single-stranded, negative-sense RNA virus. Since 1976 several Ebolavirus outbreaks have occurred with fatality rates ranging from 57% to 90%, with most of these outbreaks traced to single EBOV species; EBOV-Z. No effective therapy is currently available for Ebolavirus. AVI-6002 is an experimental combination of 2 phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically target viral messenger RNA encoding 2 Ebolavirus proteins thought to be important in viral replication and host immune suppression. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-6002 in healthy human subjects.

Interventions

DRUGPlacebo

Normal saline

DRUGAVI-6002

Single intravenous administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events	28 Days	The frequency and severity of adverse events will be monitored through 28 days post administration.

Secondary

Measure	Time frame
Drug concentration in plasma	28 days
Drug concentration in urine	28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026