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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Ebola Hemorrhagic Fever
- Sponsor
- Sarepta Therapeutics, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Placebo
Intervention: Placebo
AVI-6002
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Intervention: AVI-6002
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: 28 Days
The frequency and severity of adverse events will be monitored through 28 days post administration.
Secondary Outcomes
- Drug concentration in plasma(28 days)
- Drug concentration in urine(28 days)