Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGD014 · 1 trial · 1 indication
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...
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MGD014 is an investigational monoclonal antibody being studied for the treatment of HIV-1 infection. It is intended for HIV-1-infected individuals who are on suppressive antiretroviral therapy. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
MGD014 is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol MGNX. The company is conducting clinical research to evaluate the safety and activity of this investigational monoclonal antibody in patients with HIV-1 infection.
MGD014 is in Phase 1 clinical development. A Phase 1 study of MGD014 in HIV-1-infected individuals on suppressive antiretroviral therapy has been completed. The drug remains investigational and has not received approval from the U.S. Food and Drug Administration or other regulatory bodies.
MGD014 has been evaluated in one clinical trial with the identifier NCT03570918, titled "MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy." This Phase 1 study enrolled 21 participants in the United States and has been completed. The trial was controlled but not randomized or double-blinded.
MGD014 is a monoclonal antibody designed to target HIV-1. As an antibody-based therapy, it is intended to bind to components of the virus or infected cells to help the immune system fight the infection. The specific molecular target of MGD014 has not been disclosed in available information.