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Also known as Zika Virus Immune Globulin (ZIKV-IG)
Zika Virus Immune Globulin · 1 trial · 2 indications
Number of subjects with of adverse events by severity.
| Arm | Type | Description |
|---|---|---|
| Zika Virus Immune Globulin (ZIKV-IG) | EXPERIMENTAL | Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes. |
| Placebo (Saline Solution) | PLACEBO_COMPARATOR | Single dose of 50 mL placebo will be administered intravenously over 33 minutes. |
| Name | Type | Description |
|---|---|---|
| Zika Virus Immune Globulin (ZIKV-IG) | BIOLOGICAL | Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus. |
| Placebo | OTHER | Placebo is a normal saline solution (0.9% sodium chloride). |
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 under...
Zika Virus Immune Globulin is being developed for the prevention or treatment of Zika virus infection. It is an investigational product and has not been approved for any indication. The Phase 1 study enrolled healthy adult volunteers rather than patients with Zika virus disease.
Zika Virus Immune Globulin is being developed by Emergent BioSolutions Inc., which trades on the New York Stock Exchange under the ticker EBS. The company sponsored the Phase 1 study of the product in healthy volunteers.
Zika Virus Immune Globulin is in Phase 1 clinical development. The only reported trial was a completed Phase 1 study in healthy volunteers. It is an investigational product and is not approved by the FDA or any other regulatory agency for Zika virus infection.
Zika Virus Immune Globulin has been studied in one clinical trial, NCT03624946, titled Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG). The Phase 1 trial was completed, enrolled 30 participants, was randomized, double-blind, and placebo-controlled, and was conducted in Canada.
Yes, Zika Virus Immune Globulin is also known as ZIKV-IG. ZIKV-IG is the abbreviated name used for the same investigational product developed by Emergent BioSolutions Inc. for Zika virus infection.
Zika Virus Immune Globulin is a monoclonal antibody. Monoclonal antibodies are designed to bind to specific targets, but the precise molecular target of Zika Virus Immune Globulin has not been disclosed. It is being evaluated as an investigational product for Zika virus infection.