NCT02376036

Phase 1 Study of MGD010 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-03-03
• Last updated: 2022-02-08

Locations

1 site across 1 country: United States