Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)
Condition: Zika Virus Infection; Zika Virus Disease
MeSH terms: Virus Diseases; Zika Virus Infection
Intervention: Zika Virus Immune Globulin (ZIKV-IG); Placebo
Intervention description: Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.; Placebo is a normal saline solution (0.9% sodium chloride).
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Zika virus; Human immune globulin; Hyperimmune; Polyclonal antibodies

Summary:

      Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet
      medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic
      intervention against Zika virus infection. In this first-in-human study, evaluation of
      ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted
      in healthy adult volunteers.
    

Eligibility criteria:

        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.