Phase 1 Study of MGD010 in Healthy Subjects

MacroGenics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: Hepatitis A vaccine; Drug: Placebo; Drug: MGD010

Study type: Interventional

Funder types: Industry

Identifiers

NCT02376036

CP-MGD010-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 4 patient groups, including a placebo group

MGD010

Experimental group

Description:

Subjects will receive MGD010 through IV infusion.

Treatment:

Drug: MGD010

Placebo

Placebo Comparator group

Description:

Subjects will receive placebo through IV infusion.

Treatment:

Drug: Placebo

MGD010 and HepA vaccine

Experimental group

Description:

Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.

Treatment:

Drug: MGD010

Biological: Hepatitis A vaccine

Placebo and HepA vaccine

Placebo Comparator group

Description:

Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.

Treatment:

Biological: Hepatitis A vaccine

Drug: Placebo