Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03624946 | Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG) | PHASE1 | COMPLETED | 30 | — | — | Jun 27, 2018 | Mar 6, 2019 | Mar 18, 2024 | 1 | Canada |
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...