Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)

This is an interventional prevention trial for Zika Virus Infection focused on measuring Zika virus, Human immune globulin, Hyperimmune, Polyclonal antibodies Read More

Inclusion Criteria:

1. Informed consent voluntarily signed by subject.
2. Age: 18-55 years of age.
3. Blood type O+ or O-.

4. Body mass index (BMI) of 18-30.

   • Note: minimum body weight of 50 kg.

5. For female subjects (with male partners) that are not surgically sterilized (e.g., did not undergo hysterectomy, bilateral oophorectomy or tubal ligation), use of an effective method of contraception throughout the trial including:

   • Using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to screening and willing to continue to use hormonal contraception throughout the entire trial.
   • Intrauterine device (IUD) inserted at least 1 month prior to screening.
   • Double barrier type of birth control measure (e.g., condoms, diaphragms, cervical sponge with spermicide).
   • True abstinence.
   • For female subjects who are post-menopausal, documented follicle- stimulating hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL) must be obtained. If the FSH is <40 mIU/mL, the subject must agree to use an acceptable form of contraception (see above).
   • Females of childbearing potential without male sexual partners must be willing to maintain their sexual status as it is throughout the study.

6. For male subjects that have not had a vasectomy, use of a condom with spermicide or true abstinence for the duration of the study. Note: female partners (that are of childbearing potential) of male study subjects (that have not had a vasectomy) should use one of the effective contraception methods (eg, hormonal contraception, IUD or barrier type). Also, male subjects must not donate sperm for the duration of the study.

   • Males without female sexual partners must be willing to maintain their sexual status as it is throughout the study.
7. Healthy as determined by principal investigator or a qualified designate based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening.

Exclusion Criteria:

1. Use of any investigational product within the past 30 days.
2. Use of any investigational product during the study.
3. Individuals with blood type A, B or AB.
4. Recipient of any blood product within the past 12 months.
5. Plasma donation within 7 days or significant blood loss or blood donation within 56 days of baseline.
6. Blood donation at any time during the study.
7. Females with a hemoglobin level ≤120 g/L.
8. Males with a hemoglobin level <130 g/L.
9. History of hypersensitivity to blood or plasma products.
10. History of allergy to latex or rubber.
11. History of immunoglobulin A (IgA) deficiency.
12. History of hypercoagulable conditions (e.g., deep vein thrombosis or pulmonary embolism).
13. History of myocardial infarction.
14. History of stroke.
15. History of renal impairment/failure.
16. Currently pregnant or lactating or planning to become pregnant during the study.
17. History of flavivirus infection [ZIKV, dengue virus (DENV), West Nile virus (WNV), Japanese encephalitis virus (JEV), yellow fever virus (YFV)] or vaccination with licensed or investigational flavivirus vaccine.
18. Plans to travel to an area with active flavivirus (e.g., ZIKV and/or DENV) transmission during the study (and up to 10 months after the study drug administration) or has returned from an endemic area with these diseases within 30 days of screening.
19. Positive nucleic acid test (NAT) or serology for ZIKV or positive serology for WNV or DENV.
20. Positive serology test (at screening) for human immunodeficiency virus 1 and 2 (HIV), hepatitis C virus (HCV); positive test for hepatitis B virus (HBV) as determined by HBsAg.
21. History of chronic or acute severe neurologic condition (e.g., diagnosis of Guillain-Barre syndrome, epilepsy, Bell's palsy, meningitis or disease with any focal neurologic deficits).
22. Heavy smokers (≥15cigarettes a day) or electronic cigarette use.
23. History of, or suspected substance abuse problem (including alcohol).
24. Failure of drug (urine) test at screening or baseline.
25. Failure of alcohol (breath) test at screening or baseline.
26. Receipt of a live vaccine within 28 days prior to screening or anticipated receipt of a live vaccine during the study period.
27. Individuals with planned surgical procedures that will occur during the study.
28. An opinion of the investigator that it would be unwise to allow participation of the subject in the study.