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 studied in healthy subjects. It is in Phase 1 clinical development, with one completed trial that enrolled 73 participants in the United States. The drug is not approved and remains under investigation.
MGD010 is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX. The company conducted a Phase 1 study of MGD010 in healthy subjects.
MGD010 is in Phase 1 clinical development. A Phase 1 study of MGD010 in healthy subjects has been completed. The drug is investigational and has not been approved by regulatory authorities.
MGD010 has one completed clinical trial, identified as NCT02376036, titled 'Phase 1 Study of MGD010 in Healthy Subjects.' This trial enrolled 73 participants in the United States and was a randomized, double-blind, placebo-controlled study.
MGD010 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy subjects. The drug remains in clinical development and has not been authorized for commercial use.