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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02376036 | Phase 1 Study of MGD010 in Healthy Subjects | PHASE1 | COMPLETED | 73 | — | — | Feb 1, 2015 | Feb 1, 2017 | Feb 8, 2022 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| MGD010 | EXPERIMENTAL | Subjects will receive MGD010 through IV infusion. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive placebo through IV infusion. |
| MGD010 and HepA vaccine | EXPERIMENTAL | Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection. |
| Placebo and HepA vaccine | PLACEBO_COMPARATOR | Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection. |
| Name | Type | Description |
|---|---|---|
| MGD010 | DRUG | MGD010 is a CD32B x CD79B bi-specific antibody-based molecular construct referred to as a Dual Affinity Re-Targeting (DART) molecule. MGD010 will be administered as a single agent. |
| Placebo | DRUG | Placebo comparator. |
| Hepatitis A vaccine | BIOLOGICAL | Hepatitis A vaccine, inactivated |
Inclusion Criteria: * Between 18 and 50 years of age * Body mass index (BMI) of 18 to 30 kg/m2, inclusive Exclusion Criteria: * Women of child-bearing potential; * Women who are pregnant or breast-feeding * Any significant acute or chronic medical illness * Any major surgery within 4 weeks of stu...