Phase 1 Study of MGD010 in Healthy Subjects

MacroGenics73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Subjects

Interventions

MGD010DRUG

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.

PlaceboDRUG

Placebo comparator.

Hepatitis A vaccineBIOLOGICAL

Hepatitis A vaccine, inactivated

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PAREXEL Baltimore Early Phase Clinical Unit

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Safety and Tolerability as assessed by AEs and SAEs

Time frame: up to Day 57

Secondary Outcomes

Serum concentration (pharmacokinetics) of MGD010

Time frame: up to Day 57

Incidence of MGD010 anti-drug antibodies (ADA)

Time frame: up to Day 57

Data from ClinicalTrials.gov

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