Phase 1 Study of MGD010 in Healthy Subjects - Full Text View

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:

MedlinePlus related topics: Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	February 24, 2015
Last Updated:	March 28, 2017

Keywords provided by MacroGenics:


Normal healthy volunteer

Additional relevant MeSH terms:


Vaccines Antibodies, Bispecific Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017