Ph1 Study of Valortim and Ciprofloxacin in Humans

Inclusion Criteria

• •1. Healthy Normal male or female subjects 18 to 59 years of age on Day -1 of the study
• •2. Subject must have read, understood, and provided written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures
• •3. In the opinion of the Investigator, subjects should be in generally good health, based upon prestudy medical history, physical examination, ECG and laboratory tests
• •4. Laboratory screening values (i.e., hematology, clinical chemistries and urinalysis tests) must be within study-defined ranges
• •5. No detectable antibody to B. anthracis Protective Antigen (PA-IgG) as measured by ELISA testing at study Screening
• •6. Women of childbearing potential may be enrolled if one of the following criteria applies:
• •1. Must be using an effective form of contraception (e.g., oral contraceptives, vaginal ring, IUD, injected or implanted hormonal contraception, double barrier method of condom and spermicide, diaphragm with spermicide or sponge with spermicide) for at least one month prior to study entry, must have maintained a normal menstrual pattern for the three months prior to study entry and have a negative pregnancy test at the time of admission to the unit. Women must be willing to continue this contraception throughout the course of the study.
• •2. Is sexually abstinent
• •3. Is monogamous with a vasectomized partner (\> 3 months prior)
• •4. Is postmenopausal (i.e., no cycle for at least the previous 12 months, is of menopausal age (\> 45 years) and has a negative urine pregnancy test prior to enrollment into the study and a negative serum pregnancy test on Day -1)
• •5. Is surgically sterilized (confirmed by medical record review)
• •6. Has had a total hysterectomy a minimum of 3 months prior to dosing on Day 1 (confirmed by medical record review)
• •7. Sexually active male subjects may be enrolled if one of the following criteria applies:
• •1. Has had a vasectomy (\> 3 months prior to study entry, confirmed by medical record review)
• •2. Using condoms and whose partner is using an acceptable form of contraception (IUD, oral contraceptives, birth control patch or vaginal ring, injectable or implanted contraceptives, or tubal ligation \[surgical sterilization\]) for the duration of the study
• •3. Is sexually abstinent
• •8. Female subjects must have a negative urine pregnancy test at study Screening and a negative serum pregnancy test on admission to the Phase I unit at Day -1
• •9. Female subject who are using injectable, transdermal, vaginal ring, oral contraceptives, or an IUD must agree to also use a barrier method (i.e. male condom, female condom, diaphragm, cervical cap) for the duration of their participation in the study.
• •10. Agreement to not receive any vaccinations from Day -1 through to 31 days post Valortim dosing. Vaccination against B. anthracis is prohibited during the study
• •11. Body Mass Index (BMI) ≥ 19 and ≤ 30
• •12. Abstinence from alcohol for 24 hours prior to study drug administration until discharge from the Phase I unit