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
Overview
- Phase
- Phase 1
- Intervention
- AVI-7537
- Conditions
- Ebola Hemorrhagic Fever
- Sponsor
- Sarepta Therapeutics, Inc.
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
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 7537 compared to matched placebo in and to evaluate the pharmacokinetics (PK).
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject must meet all of the following criteria to be eligible for this study.
- •Man or woman 18 to 50 years of age, inclusive, at the time of screening.
- •Body mass index 18 kg/m2 to 35 kg/m2, inclusive, at the time of screening and Check-in (Day -1).
- •Good general health (no chronic health conditions) as determined by the Investigator.
- •Female subjects must be of non-childbearing potential (e.g., be confirmed post-menopausal or have undergone surgical sterilization) or must, in conjunction with their sexual partner(s), use 2 forms of medically acceptable contraception (e.g., oral contraception in conjunction with a male condom) during the screening period and for the entire duration of the study including the 28-day post last dose follow-up.
- •Male subjects must either be sterile or agree to use, for the entire duration of the study including the 28 day post last dose follow-up, a male condom and the female sexual partner must also use a medically acceptable form of birth control (e.g. oral contraceptives).
- •Male subjects must agree to not donate sperm for at least 30 days after the last infusion of study medication.
- •Able to understand the requirements of the study, to provide written informed consent (as evidenced by signature on an informed consent document that is approved by an Institutional Review Board \[IRB\]), and agreeable to abiding by the study restrictions.
Exclusion Criteria
- •A subject who meets any of the following criteria will be excluded from this study.
- •Pregnancy or breastfeeding.
- •A positive urine or blood screen for drugs of abuse, including alcohol.
- •Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1).
- •A positive cotinine test indicating recent nicotine use.
- •Donated blood within 90 days or plasma within 30 days of first dose on Day
- •Active substance abuse or any medical or psychiatric condition that could jeopardize the subject's safety or the subject's ability to comply with the protocol.
- •Use of any medications apart from vitamins, acetaminophen, or hormonal contraception within 14 days of first dose on Day
- •Subjects with mild seasonal allergies may use antihistamines at the discretion of the Investigator after approval by the Sponsor Medical Monitor.
- •Participation in any interventional clinical trial within 45 days of first dose on Day 1 (i.e., received any other investigational drug).
Arms & Interventions
AVI-7537
AVI-7537
Intervention: AVI-7537
Placebo
Normal Saline Solution (NSS)
Intervention: Normal Saline Solution (NSS)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- To evaluate the pharmacokinetics (PK) of 14 once daily doses of AVI-7537 in healthy male and female subjects,(2 weeks)