Phase 1 Study of MGD010 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MGD010

Subjects will receive MGD010 through IV infusion.

Group Type EXPERIMENTAL

MGD010

Intervention Type DRUG

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.

Placebo

Subjects will receive placebo through IV infusion.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator.

MGD010 and HepA vaccine

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

Group Type EXPERIMENTAL

MGD010

Intervention Type DRUG

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.

Hepatitis A vaccine

Intervention Type BIOLOGICAL

Hepatitis A vaccine, inactivated

Placebo and HepA vaccine

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator.

Hepatitis A vaccine

Intervention Type BIOLOGICAL

Hepatitis A vaccine, inactivated

Interventions

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MGD010

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.

Intervention Type DRUG

Placebo

Placebo comparator.

Intervention Type DRUG

Hepatitis A vaccine

Hepatitis A vaccine, inactivated

Intervention Type BIOLOGICAL

Other Intervention Names

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Vaqta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes