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Phase 1 Study of MGD010 in Healthy Subjects

NCT02376036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-02-08

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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.

DRUG

Placebo

Placebo comparator.

BIOLOGICAL

Hepatitis A vaccine

Hepatitis A vaccine, inactivated

Sponsors & Collaborators

Principal Investigators

  • Chief Medical Officer · MacroGenics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376036 on ClinicalTrials.gov