NCT02376036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 24, 2015

Last Update Submit

February 4, 2022

Conditions

Healthy Subjects

Keywords

Normal healthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability as assessed by AEs and SAEs

    up to Day 57

Secondary Outcomes (2)

  • Serum concentration (pharmacokinetics) of MGD010

    up to Day 57

  • Incidence of MGD010 anti-drug antibodies (ADA)

    up to Day 57

Study Arms (4)

MGD010

EXPERIMENTAL

Subjects will receive MGD010 through IV infusion.

Drug: MGD010

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo through IV infusion.

Drug: Placebo

MGD010 and HepA vaccine

EXPERIMENTAL

Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.

Drug: MGD010Biological: Hepatitis A vaccine

Placebo and HepA vaccine

PLACEBO COMPARATOR

Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.

Drug: PlaceboBiological: Hepatitis A vaccine

Interventions

MGD010DRUG

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.

MGD010MGD010 and HepA vaccine
PlaceboDRUG

Placebo comparator.

PlaceboPlacebo and HepA vaccine
Hepatitis A vaccineBIOLOGICAL

Hepatitis A vaccine, inactivated

Also known as: Vaqta
MGD010 and HepA vaccinePlacebo and HepA vaccine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 50 years of age
  • Body mass index (BMI) of 18 to 30 kg/m2, inclusive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAREXEL Baltimore Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Hepatitis A Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Chief Medical Officer

    MacroGenics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 3, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

US(1)