Phase 1 Study of MGD010 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02376036

Recruitment Status : Completed

First Posted : March 3, 2015

Last Update Posted : March 29, 2017

Sponsor:

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

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 :

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 ]

Eligibility Criteria

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 Posted:	March 3, 2015 Key Record Dates
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

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