Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGD010 · 1 trial · 1 indication
| 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...
MGD010 is an investigational small molecule being developed by MacroGenics, Inc. It is a bispecific molecule that targets CD32B and CD79B. It has been studied in a Phase 1 clinical trial in healthy adult subjects. No approved indication has been announced for MGD010.
MGD010 targets CD32B and CD79B. It is designed as a bispecific molecule, meaning it binds two distinct targets. CD32B is an inhibitory Fc receptor, and CD79B is a component of the B cell receptor complex. Both targets are associated with B cell signaling pathways.
MGD010 is being developed by MacroGenics, Inc., which trades on the Nasdaq under the ticker MGNX. MacroGenics is a clinical-stage biopharmaceutical company. The company sponsored the Phase 1 study of MGD010 conducted in the United States.
MGD010 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial of MGD010 has been completed, and no active trials are currently listed for the program.
MGD010 has been evaluated in one completed Phase 1 trial, NCT02376036, titled Phase 1 Study of MGD010 in Healthy Subjects. The trial enrolled 73 healthy adult volunteers in the United States. It was randomized, double-blind, and placebo-controlled.