A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers
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|ClinicalTrials.gov Identifier: NCT01566877|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : May 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Marburg Hemorrhagic Fever||Drug: AVI-7288 Other: Placebo||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
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.
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 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 ]
- 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 ]Efficacy will not be assessed in a Phase I study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566877
|United States, Maryland|
|SNBL Clinical Pharmacology Center, Inc.|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Mohamed Al-Ibrahim, MD||SNBL|