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Phase 1 Study of MGD010 in Healthy Subjects

Sponsor
MacroGenics (Industry)
Overall Status
Completed
CT.gov ID
NCT02376036
Collaborator
(none)
73
Enrollment
1
Location
4
Arms
24
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: MGD010
  • Drug: Placebo
  • Biological: Hepatitis A vaccine
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
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
Actual Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Vaqta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability as assessed by AEs and SAEs [up to Day 57]

    Secondary Outcome Measures

    1. Serum concentration (pharmacokinetics) of MGD010 [up to Day 57]

    2. Incidence of MGD010 anti-drug antibodies (ADA) [up to Day 57]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 PAREXEL Baltimore Early Phase Clinical Unit Baltimore Maryland United States 21225

    Sponsors and Collaborators

    • MacroGenics

    Investigators

    • Study Director: Chief Medical Officer, MacroGenics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MacroGenics
    ClinicalTrials.gov Identifier:
    NCT02376036
    Other Study ID Numbers:
    • CP-MGD010-01
    First Posted:
    Mar 3, 2015
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by MacroGenics
    Normal healthy volunteer

    Study Results

    No Results Posted as of Feb 8, 2022