Clinical Trial: A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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).
Detailed Summary:
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
Sponsor: Sarepta Therapeutics
Current Primary Outcome: 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 ]
Original Primary Outcome: 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 ]
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Sarepta Therapeutics
Dates:
Date Received: March 27, 2012
Date Started: May 2013
Date Completion:
Last Updated: May 6, 2014
Last Verified: May 2014
