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The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010 intravenous (IV) infusion in healthy adult volunteers.
This is a Phase 1 study to evaluate the safety, tolerability and PK of MGD010, a CD32B x CD79B DART bi-specific antibody-based molecule. This study will be conducted as a double-blind, randomized, placebo controlled, single ascending dose study among healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGD010 | Experimental | Subjects will receive MGD010 through IV infusion. |
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| Placebo | Placebo Comparator | Subjects will receive placebo through IV infusion. |
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| MGD010 and HepA vaccine | Experimental | Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection. |
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| Placebo and HepA vaccine | Placebo Comparator | Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as assessed by AEs and SAEs | up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration (pharmacokinetics) of MGD010 | up to Day 57 | |
| Incidence of MGD010 anti-drug antibodies (ADA) | up to Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | MacroGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Baltimore Early Phase Clinical Unit | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Placebo | Drug | Placebo comparator. |
|
| Hepatitis A vaccine | Biological | Hepatitis A vaccine, inactivated |
|
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| D045424 |
| Complex Mixtures |