Phase 1 Study of MGD010 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: MGD010; Biological: Hepatitis A vaccine

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel Baltimore Early Phase Clinical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability as assessed by AEs and SAEs	up to Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum concentration (pharmacokinetics) of MGD010	up to Day 57
Incidence of MGD010 anti-drug antibodies (ADA)	up to Day 57

Collaborators and Investigators

• Sponsor: MacroGenics

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Normal healthy volunteer
• Other Study ID Numbers: CP-MGD010-01