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Keep this study
Lead
MacroGenics
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.
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Between 18 and 50 years of age
Body mass index (BMI) of 18 to 30 kg/m2, inclusive
You may not be if
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
Clareo Health | Phase 1 Study of MGD010 in Healthy Subjects
