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Phase 1 Study of MGD010 in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02376036
First Posted: March 3, 2015
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MacroGenics
  Purpose
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.

Condition Intervention Phase
Healthy Subjects Drug: MGD010 Drug: Placebo Biological: Hepatitis A vaccine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by MacroGenics:

Primary Outcome Measures:
  • Safety and Tolerability as assessed by AEs and SAEs [ Time Frame: up to Day 57 ]

Secondary Outcome Measures:
  • Serum concentration (pharmacokinetics) of MGD010 [ Time Frame: up to Day 57 ]
  • Incidence of MGD010 anti-drug antibodies (ADA) [ Time Frame: up to Day 57 ]

Enrollment: 73
Actual Study Start Date: February 2015
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGD010
Subjects will receive MGD010 through IV infusion.
Drug: 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.
Placebo Comparator: Placebo
Subjects will receive placebo through IV infusion.
Drug: Placebo
Placebo comparator.
Experimental: MGD010 and HepA vaccine
Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.
Drug: 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.
Biological: Hepatitis A vaccine
Hepatitis A vaccine, inactivated
Other Name: Vaqta
Placebo Comparator: Placebo and HepA vaccine
Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.
Drug: Placebo
Placebo comparator.
Biological: Hepatitis A vaccine
Hepatitis A vaccine, inactivated
Other Name: Vaqta

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376036


Locations
United States, Maryland
PAREXEL Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
MacroGenics
Investigators
Study Director: Sadhna Shankar, MD MacroGenics
  More Information

Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT02376036     History of Changes
Other Study ID Numbers: CP-MGD010-01
First Submitted: February 24, 2015
First Posted: March 3, 2015
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by MacroGenics:
Normal healthy volunteer

Additional relevant MeSH terms:
Vaccines
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs