Phase 1 Study of MGD010 in Healthy Subjects
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02376036 |
Recruitment Status :
Completed
First Posted : March 3, 2015
Last Update Posted : February 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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Healthy Subjects | Drug: MGD010 Drug: Placebo Biological: Hepatitis A vaccine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MGD010, a CD32B x CD79B Dual Affinity Re-Targeting (DART®) Bi-specific Antibody-Based Molecule, in Healthy Subjects |
Actual Study Start Date : | February 2015 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | February 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: MGD010
Subjects will receive MGD010 through IV infusion.
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Drug: MGD010
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 Comparator: Placebo
Subjects will receive placebo through IV infusion.
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Drug: Placebo
Placebo comparator. |
Experimental: MGD010 and HepA vaccine
Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.
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Drug: MGD010
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. Biological: Hepatitis A vaccine Hepatitis A vaccine, inactivated
Other Name: Vaqta |
Placebo Comparator: Placebo and HepA vaccine
Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.
|
Drug: Placebo
Placebo comparator. Biological: Hepatitis A vaccine Hepatitis A vaccine, inactivated
Other Name: Vaqta |
- Safety and Tolerability as assessed by AEs and SAEs [ Time Frame: up to Day 57 ]
- Serum concentration (pharmacokinetics) of MGD010 [ Time Frame: up to Day 57 ]
- Incidence of MGD010 anti-drug antibodies (ADA) [ Time Frame: up to Day 57 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 study drug administration
- Active or latent tuberculosis (TB)
- Active or latent Hepatitis B, Hepatitis C or HIV infection
- History of allergy to monoclonal antibodies, any significant drug allergy (such as anaphylaxis), or hypersensitivity to any components of the test or reference investigational product formulation.
- Evidence of organ dysfunction or any clinically significant deviation from normal
- Vaccination with any live vaccine, or use of any prescription drugs, within 4 weeks of study drug administration
- Known history of infection or exposure to Hepatitis A virus

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376036
United States, Maryland | |
PAREXEL Baltimore Early Phase Clinical Unit | |
Baltimore, Maryland, United States, 21225 |
Study Director: | Chief Medical Officer | MacroGenics |
Responsible Party: | MacroGenics |
ClinicalTrials.gov Identifier: | NCT02376036 |
Other Study ID Numbers: |
CP-MGD010-01 |
First Posted: | March 3, 2015 Key Record Dates |
Last Update Posted: | February 8, 2022 |
Last Verified: | February 2022 |
Normal healthy volunteer |