Skip to main content
OpenTrials
Completed

NCT Number: NCT02376036

Phase 1 Study of MGD010 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL Baltimore Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MGD010

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

Drug

Placebo comparator.

Hepatitis A Vaccine

Biological

Hepatitis A vaccine, inactivated

Other names: Vaqta

Primary outcomes

  1. Safety and Tolerability as assessed by AEs and SAEs

    Time frame: up to Day 57

Secondary outcomes

  1. Serum concentration (pharmacokinetics) of MGD010

    Time frame: up to Day 57

  2. Incidence of MGD010 anti-drug antibodies (ADA)

    Time frame: up to Day 57

Sponsors and collaborators

Lead sponsor

MacroGenics

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2015
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.