October 2011 By NovaDigm Therapeutics, Inc.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||Accepts Healthy Volunteers|
1. Informed of the nature of the study and have agreed to and are able to read, review,
and sign the informed consent document prior to screening. The informed consent
document will be written in English, therefore the volunteer must have the ability to
read and communicate in English.
2. Completed the screening process (as described in this protocol) within 28 days prior
3. Healthy male and female volunteers 18-50 years of age, inclusive, at the time of
4. No clinically significant deviation from normal as judged by the investigator(s) in
the medical history, physical examination (including but may not be limited to an
evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous
systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical
laboratory assessments, and by general observations.
5. Female volunteers must be one of the following:
- of childbearing potential and practicing an acceptable method of birth control
as judged by the Investigator(s)
- naturally postmenopausal (no menses) for at least 1 year and has a documented
FSH level ? 40 mIU/mL
- surgically postmenopausal (bilateral oophorectomy or hysterectomy)
- sterile (surgically [bilateral tubal ligation] or the Essure? Procedure) Female
volunteers that are surgically sterile or surgically postmenopausal must provide
documentation of the bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy prior to dosing or the volunteer must agree to use a medically
acceptable method of birth control. The Essure? Procedure must have been
inserted at least 3 months prior with documentation of the Essure? confirmation
test prior to Period I dosing. If the procedure was inserted less than 3 months
prior to Period I dosing or proper documentation of the confirmation test is not
provided, the volunteer must agree to use an additional medically acceptable
method of birth control.
1. Reports receiving any investigational drug, investigational vaccine, or
investigational device within 30 days prior to dosing.
2. Reports any presence or history of a clinically significant disorder involving the
cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
endocrine, or neurologic system(s) or psychiatric disease as determined by the
3. Clinical laboratory test values outside the accepted range.
4. When confirmed upon additional testing, demonstrates a reactive screen for hepatitis
B surface antigen, hepatitis C antibody, or HIV antibody.
5. Demonstrates a positive drug screen for non-prescription drugs.
6. Reports a clinically significant illness during the 28 days prior to dosing (as
determined by the Investigator[s]).
7. Reports a history of allergic response(s) to nickel or anaphylaxis (or other serious
reactions) to aluminum.
8. Reports receiving any live attenuated vaccine including FluMist? within 6 weeks prior
to dosing or any licensed inactivated vaccine within 3 weeks prior to dosing.
9. Reports the use of any immunosuppressive drugs, including systemic corticosteroids,
within 4 weeks prior to dosing.
10. Reports the use of any medications or treatments that may alter immune responses to
the study vaccine within 3 weeks prior to dosing (eg, cyclosporine, tacrolimus,
cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal
antibodies, radiation therapy).
11. Reports a history of clinically significant allergies including food or drug
allergies or anaphylaxis (or other serious reactions) to vaccines.
12. Reports a history of drug or alcohol addiction or abuse within the past year.
13. Reports receiving any blood products within 3 months prior to dosing and throughout
14. Reports donating blood within 28 days prior to dosing. All subjects will be advised
not to donate blood for four weeks after completing the study.
15. Reports donating plasma (e.g. plasmapheresis) within 14 days prior to dosing. All
subjects will be advised not to donate plasma for four weeks after completing the
16. Demonstrates, in the opinion of study staff, veins unsuitable for repeated
venipuncture (e.g. veins difficult to locate, access, or puncture; veins with a
tendency to rupture during or after puncture).
17. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of
18. Demonstrates a positive pregnancy screen.
19. Reports smoking or using tobacco products or is currently using nicotine products
(patches, gums, etc). Thirty (30) days abstinence prior to dosing is required.
20. Any other medical and/or social (e.g. uncooperative or non-compliant) reason which,
in the opinion of the investigator(s), would prevent participation in the study.