Phase 1 Study of MGD010 in Healthy Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:3/30/2017
Start Date:February 2015
End Date:February 2017

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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
1
site
Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland 21225
Principal Investigator: Ronald Goldwater, MD
Phone: 410-350-7979
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mi
from
Baltimore, MD
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