A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7537 in Healthy Adult Volunteers

Brief Title

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7537 in Healthy Adult Volunteers

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

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
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 To evaluate the pharmacokinetics (PK) of 14 once daily doses of AVI-7537 in healthy male and female subjects,

Condition

Ebola Hemorrhagic Fever

Intervention

AVI-7537

Study Arms / Comparison Groups

 AVI-7537
Description:  AVI-7537

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

August 2012

Completion Date

January 2013

Primary Completion Date

January 2013

Eligibility Criteria

        Inclusion Criteria:

        A subject must meet all of the following criteria to be eligible for this study.

          1. Man or woman 18 to 50 years of age, inclusive, at the time of screening.

          2. Body mass index 18 kg/m2 to 35 kg/m2, inclusive, at the time of screening and Check-in
             (Day -1).

          3. Good general health (no chronic health conditions) as determined by the Investigator.

          4. 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.

          5. 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).

          6. Male subjects must agree to not donate sperm for at least 30 days after the last
             infusion of study medication.

          7. 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.

          1. Pregnancy or breastfeeding.

          2. A positive urine or blood screen for drugs of abuse, including alcohol.

          3. 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).

          4. A positive cotinine test indicating recent nicotine use.

          5. Donated blood within 90 days or plasma within 30 days of first dose on Day 1.

          6. 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.

          7. Use of any medications apart from vitamins, acetaminophen, or hormonal contraception
             within 14 days of first dose on Day 1. Subjects with mild seasonal allergies may use
             antihistamines at the discretion of the Investigator after approval by the Sponsor
             Medical Monitor.

          8. Participation in any interventional clinical trial within 45 days of first dose on Day
             1 (i.e., received any other investigational drug).

          9. Recipient of an organ transplant (solid or hematopoietic).

         10. Prolonged QTcF interval > 440 ms for males or > 460 ms for females using the average
             of the triplicate electrocardiograms (ECGs) collected during screening, on Day -1, or
             just prior to dosing on Day 1.

         11. Other clinically significant ECG abnormality, as determined by the Investigator.

         12. Any clinically significant abnormal hematology, chemistry, coagulation, or urinalysis
             value, as determined by the Investigator.

         13. Glomerular filtration rate (GFR) of < 80 mL/min, based on the Modification of Diet in
             Renal Disease equation.

         14. Urine-albumin-to-creatinine ratio (UACR) > 30 mg/g.

         15. Positive test for human immunodeficiency virus (HIV-1 serology) or known HIV
             infection.

         16. Positive result for hepatitis B surface antigen (HBsAg) or for hepatitis C virus (HCV)
             antibody.

         17. Use of alcohol-containing foods or beverages within 72 hours prior to Check-in on Day
             -1.

         18. Use of caffeine-containing foods or beverages within 24 hours prior to Check-in on Day
             -1.

         19. Febrile illness or significant infection within 48 hours before administration of the
             first dose of study drug on Day 1.

        Note: Inclusion of each subject will be reviewed with a member of AVI BioPharma Clinical
        Personnel prior to enrollment in the trial. Written approval from a member of AVI BioPharma
        Clinical Personnel is required prior to randomization.
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Alison Heald, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01593072

Organization ID

7537-us-101

Secondary IDs

W9113M-10-C-0056

Responsible Party

Sponsor

Study Sponsor

Sarepta Therapeutics, Inc.

Collaborators

 United States Department of Defense

Study Sponsor

Alison Heald, MD, Principal Investigator, Sarepta Therapeutics, Inc.


Verification Date

January 2013