A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7537 in Healthy Adult Volunteers
|ClinicalTrials.gov Identifier: NCT01593072|
Recruitment Status : Withdrawn (Terminated for convenience of the Government due to funding constraits)
First Posted : May 7, 2012
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ebola Hemorrhagic Fever||Drug: AVI-7537 Other: Normal Saline Solution (NSS)||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 7537 compared to matched placebo in healthy male and female subjects.
To evaluate the pharmacokinetics (PK) of 14 once daily doses of AVI-7537 in healthy male and female subjects
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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 A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7537 in Healthy Adult Volunteers|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2013|
Active Comparator: AVI-7537
Cohort 1: AVI-7537 at 4.5 mg/kg IV; Cohort 2: AVI-7537 at 9 mg/kg IV;Cohort 3: AVI-7537 at 15 mg/kg IV; Cohort 4: AVI-7537 at 30 mg/kg IV
The amount of AVI-7537 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.
Normal Saline Solution (NSS)
Other: Normal Saline Solution (NSS)
Normal Saline Solution (NSS)
- The outcome measures are Serial PK Day 1 over 24 hrs(pre-dose,10 min post,30 min post, 1hr 1.5,2,4,6, 8, 12,16,24,28,32,36, and 48 hrs post-dose), daily through level and on Day 14 (last day of dosing) serial PK until 48 hrs post last dose. [ Time Frame: 2 weeks ]The outcome measures are Serial PK Day 1 over 24 hours (pre-dose, 10 minutes post-dose , 30 minutes, 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). PK Day 14 over 48 hours (post-dose, 10 minutes, 1.5, 2, 4, 6, 8, 12, 16, 24, 28, 32, 36, and 48 hours post-dose (collection of plasma pre-dose on Day 14 will also serve as the trough sample for that day).
- To evaluate the pharmacokinetics (PK) of 14 once daily doses of AVI-7537 in healthy male and female subjects, [ Time Frame: 2 weeks ]Efficacy will not be assessed in a Phase I study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593072
|United States, Kansas|
|Quintiles Phase I Services|
|Overland Park, Kansas, United States, 66211|
|Principal Investigator:||Alison Heald, MD||Sarepta Therapeutics|