A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers
The purpose of this study is to evaluate the safety and tolerability of healthy male and female subjects with intravenous (IV) infusions of AVI 7288 compared to matched placebo in and to evaluate the pharmacokinetics (PK).
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers|
- The outcome measure is safety, as assessed through adverse event evaluation and serial clinical assessments. [ Time Frame: daily during dosing period with follow up on Day 21 and Day 42 ] [ Designated as safety issue: Yes ]
- The outcome measures are Serial PK Day 1 over 24 hours(predose, 10minutes post, 30 minutes post, 1 hour 1.5, 2, 4, 6,. 8, 12,16,24 hours post dose), daily trough level and on Day 14 (last day of dosing) serial PK until 48 hours post last dose. [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]Efficacy will not be assessed in a Phase I study.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: AVI-7288
AVI-7288 is a phosphorodiamidate morpholino oligomer with positive charges (PMOplus™) that targets Marburg virus nucleoprotein (NP). AVI-7288 is supplied in 5 mL vials containing 5 mL AVI-7288 at a concentration of 50 mg/mL. The dose levels of AVI-7288 will vary in four cohort's.
Cohort 1: AVI-7288 at 1 mg/kg IV; Cohort 2: AVI-7288 at 4 mg/kg IV;Cohort 3: AVI-7288 at 8 mg/kg IV; Cohort 4: AVI-7288 at 12 mg/kg IV
The amount of AVI-7288 required to administer the required dose will be diluted to a volume of approximately 150 mL with normal saline solution (NSS) and given by IV infusion over 30 minutes once a day for 14 days. Infusions will be administered at approximately the same time each day.
Other Name: AVI-7288
Placebo Comparator: Placebo
Placebo control consists of approximately 150 mL normal saline solution administered by IV infusion over 30 minutes once a day for 14 days.
Normal Saline Solution (NSS)
Other Name: Normal Saline Solution (NSS)
The purpose of this study is to evaluate the safety and tolerability of 14 once daily intravenous (IV) infusions of ascending doses of AVI 7288 compared to matched placebo in healthy male and female subjects.
To evaluate the pharmacokinetics (PK) of 14 once daily doses of AVI-7288 in healthy male and female subjects
|Contact: William Leslie, BS||(301) firstname.lastname@example.org|
|United States, Maryland|
|SNBL Clinical Pharmacology Center, Inc.||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Mohamed Al-Ibrahim, MD 866-706-8833 email@example.com|
|Contact: William Leslie (301) 370-9707 firstname.lastname@example.org|
|Principal Investigator: Mohamed S Al-Ibrahim, MD|
|Principal Investigator:||Mohamed Al-Ibrahim, MD||SNBL|