Phase 1 Study of MGD010 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT02376036
• Recruitment Status: Completed
• First Posted: March 3, 2015
• Last Update Posted: February 8, 2022
• Sponsor: MacroGenics
• Information provided by (Responsible Party): MacroGenics

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
Healthy Subjects	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 (Clinical Trial)
• 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: February 2015
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 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 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• 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

Locations

United States, Maryland

PAREXEL Baltimore Early Phase Clinical Unit

Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

MacroGenics

Investigators

• Study Director: Chief Medical Officer; MacroGenics

More Information

• Responsible Party: MacroGenics
• ClinicalTrials.gov Identifier: NCT02376036
• Other Study ID Numbers: CP-MGD010-01
• First Posted: March 3, 2015
• Last Update Posted: February 8, 2022
• Last Verified: February 2022

Keywords provided by MacroGenics:

Normal healthy volunteer