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
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This study will be evaluating safety and pharmacokinetics (PK) of one dose level of ZIKV-IG
      (50 mL) in healthy adult volunteers. The study is a single-center, double-blind, randomized
      and placebo-controlled design. The primary objective is to assess safety of intravenously
      (IV) administered ZIKV-IG, while the secondary objective is to determine the PK profile of
      ZIKV-IG in healthy adult volunteers.

      There will be a total of 30 subjects enrolled into the study; dosing of the first six
      subjects will be staggered over three separate days, wherein two subjects per day will be
      randomized 1:1 to either receive 50 mL of placebo IV or 50 mL of ZIKV-IG IV (the total amount
      of gamma immune globulin [IgG] protein from a single 50mL dose is 4.65g). After the first six
      subjects are dosed, the remaining 24 subjects will be randomized 2:1 to receive either
      ZIKV-IG or placebo. A safety monitoring committee will review safety data (collected up to 3
      days post-dosing) of the first 12 dosed subjects prior to dosing of the remaining 18
      subjects. Overall, there will be 19 subjects randomized to receive ZIKV-IG and 11 subjects
      randomized to receive placebo on Day 1. On Day 1 (post-dose at 1 hour, 3 hours, 8 hours) and
      Day 2, safety and PK assessments will be conducted while the subjects are in the Phase 1
      clinic. After the discharge on Day 2, the subjects will come back to the clinic for safety
      and PK assessments on Days 3, 4, 6, 8, 10, 12, 15, 22, 29, 43, 57 and 85. Total study
      duration for each subject will be up to 4 months (from screening to Day 85).
    

Intervention name(s): Zika Virus Immune Globulin (ZIKV-IG); Placebo
Intervention type(s): Biological; Other
Intervention description(s): 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).
Other intervention name(s): Anti-Zika Immune Globulin (Human); NP-024; Saline solution
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zika virus; Human immune globulin; Hyperimmune; Polyclonal antibodies