Approval Probability
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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 an investigational monoclonal antibody being developed for the prevention or treatment of Zika Virus Infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The product is intended for use in individuals at risk of or affected by Zika virus disease.
Zika Virus Immune Globulin is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical research to evaluate the safety and pharmacokinetics of this investigational monoclonal antibody product.
Zika Virus Immune Globulin is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the safety and pharmacokinetics of the product in healthy volunteers. The product remains investigational and is not yet approved for commercial use.
Zika Virus Immune Globulin has one completed clinical trial, identified as NCT03624946, titled 'Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)'. This Phase 1 study enrolled 30 participants in Canada and was a randomized, double-blind, placebo-controlled trial.
Yes, Zika Virus Immune Globulin is also known as ZIKV-IG. The clinical trial NCT03624946 uses the abbreviation ZIKV-IG in its title to refer to the investigational product. Both names refer to the same monoclonal antibody being developed by Emergent BioSolutions.