A Study to Assess the Safety, Tolerability and PK of a Single IV Dose of ETI-204 in Adult Volunteers

Inclusion Criteria:

1. Females or males ≥ 18 years of age

2. All females, regardless of childbearing potential, must have a negative serum beta
human chorionic gonadotropin (β-hCG) pregnancy test at Screening and Day -1

3. Females of childbearing potential (i.e., not postmenopausal or surgically sterile)
must agree to practice abstinence or to use a medically accepted method of
contraception from the time of Screening through 30 days after final study visit.
Acceptable methods of contraception include diaphragm with spermicide; sponge with
spermicide; condom with spermicide; or intrauterine device with condom or spermicide.
The following contraceptive methods are acceptable only when used with a condom and
spermicide: birth control pills, birth control patches, vaginal ring, hormone under
the skin, or hormone injections

4. Postmenopausal females, defined as females who have had amenorrhea for at least 12
months either naturally or following cessation of all exogenous hormonal treatments
and have a follicle stimulating hormone (FSH) level of > 40 mIU/mL at Screening

5. Females who have undergone surgical sterilization, including hysterectomy, bilateral
oophorectomy, bilateral salpingectomy, tubal ligation, or tubal essure

6. Males must agree to practice abstinence or use a condom with spermicide and refrain
from sperm donation during the study and for 30 days after the final study visit

7. Provide written informed consent

8. Willing to comply with study restrictions

Exclusion Criteria:

1. Pregnant or lactating woman

2. Clinically significant comorbidity that would interfere with completion of the study
procedures or objectives, or compromise the subject's safety

3. Seated systolic blood pressure (BP) ≥ 150 mmHg or ≤ 90 mmHg or diastolic BP ≥ 95
mmHg

4. Use of H1 receptor antagonists (i.e. antihistamines) within 5 days prior to Day 1

5. Evidence of drug or alcohol abuse as determined by the Investigator within 6 months
of Day 1

6. Positive test result for drugs of abuse (with the exception of medically prescribed
drugs) at Screening or on Day -1

7. Positive test for alcohol at Screening; exclusion is subject to the Investigator's
discretion; subjects who test positive for alcohol at Day -1 are excluded from the
study

8. Treatment with an investigational agent within 30 days of Day 1 or within five
half-lives of the investigational agent at Day 1 (whichever is longer)

9. Congenital or acquired immunodeficiency syndrome

10. Prior solid organ or bone marrow transplant

11. Positive test for Hepatitis B (surface antigen), Hepatitis C, or human
immunodeficiency virus (HIV) at Screening

12. History of prior treatment for anthrax exposure or prior anthrax infection

13. Prior immunization with any approved or investigational anthrax vaccine or prior
treatment with an investigational anthrax treatment (i.e., ETI-204, raxibacumab, or
anthrax immune globulin)

14. Military personnel deployed in 1990 or after, unless the subject can provide
documentation demonstrating they have not previously received any approved or
investigational anthrax vaccine

15. Use of systemic steroids, immunosuppressive agents, anticoagulants, or
anti-arrhythmics within 1 year prior to Day 1. A single short course (i.e., less
than 14 days) of systemic steroid therapy is allowed provided it concluded more than
6 months prior to Day 1

16. Donation or loss of > 500 mL of blood within 30 days or plasma within 7 days of Day 1

17. Prior stroke, epilepsy, relapsing or degenerative central nervous system disease, or
relapsing or degenerative ocular disease

18. Myocardial infarction or acute coronary syndrome in the past 5 years, active angina
pectoris, or heart failure (New York Heart Association scale > 1)

19. History of chronic liver disease

20. Calculated creatinine clearance (CrCl) of < 30 mL/min using the Cockcroft-Gault
equation

21. Any clinically significant abnormality, in the Investigator's opinion, on
electrocardiogram (ECG) or clinical laboratory tests (hematology, clinical chemistry,
or urinalysis) at Screening; Out of range results may be repeated to confirm.

22. History of allergic or hypersensitivity reactions to other therapeutic antibodies or
immunoglobulins

23. History of any malignant neoplasm within the last 5 years, with the exception of
adequately treated localized or in situ non-melanoma carcinoma of the skin (i.e.,
basal cell carcinoma) or the cervix

24. Subjects who, in the opinion of the Investigator, are not suitable candidates for
enrollment or who may not comply with the requirements of the study