Expired Study
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Baltimore, Maryland 21225


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02376036


Primary Contact:

Study Director
Sadhna Shankar, MD
MacroGenics


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21225
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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