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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03570918 | MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy | PHASE1 | COMPLETED | 21 | — | — | Sep 25, 2018 | Sep 28, 2021 | Sep 2, 2022 | 1 | United States |
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
| Arm | Type | Description |
|---|---|---|
| MGD014 0.1 micrograms/kilogram (mcg/kg) | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 0.3 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 1.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 3.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 10.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 30.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 100.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 300.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 300.0 mcg/kg multiple doses | EXPERIMENTAL | 2-hour infusion every 2 weeks for 3 infusions |
| Name | Type | Description |
|---|---|---|
| MGD014 | BIOLOGICAL | HIV-1 x CD3 bispecific DART molecule |
Inclusion Criteria: * Ability and willingness of participant to provide written informed consent. * HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blo...