Phase 1 Study of MGD010 in Healthy Subjects

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

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.

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