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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00116168 | Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528 | PHASE1 | COMPLETED | 29 | — | — | Jun 1, 2005 | Jul 1, 2006 | Dec 11, 2013 | 2 | United States |
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Number of participants with troponin levels greater than upper limit of normal
Number of participants with clinically significant changes from baseline in neurologic exam
Number of participants with changes from baseline in the Day 28 MRI of the brain
Number of participants experiencing serious adverse events
| Arm | Type | Description |
|---|---|---|
| MEDI-528 0.3 mg/kg | EXPERIMENTAL | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose |
| MEDI-528 1 mg/kg | EXPERIMENTAL | MEDI-528 (1 mg/kg) administered as a single, SC dose |
| MEDI-528 3 mg/kg | EXPERIMENTAL | MEDI-528 (3 mg/kg) administered as a single, SC dose |
| MEDI-528 9 mg/kg | EXPERIMENTAL | MEDI-528 (9 mg/kg) administered as a single, SC dose |
| Name | Type | Description |
|---|---|---|
| MEDI-528 0.3 mg/kg | BIOLOGICAL | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose |
| MEDI-528 1 mg/kg | BIOLOGICAL | MEDI-528 (1 mg/kg) administered as a single, SC dose |
| MEDI-528 3 mg/kg | BIOLOGICAL | MEDI-528 (3 mg/kg) administered as a single, SC dose |
| MEDI-528 9 mg/kg | BIOLOGICAL | MEDI-528 (9 mg/kg) administered as a single, SC dose |
Inclusion Criteria: * Males and females age 19 up to, and including, 49 years of age at the time of the first dose of study drug * Weight less than 89 kg * Written informed consent obtained from the volunteer * Healthy by medical history and physical examination * Sexually active females, unless su...