Phase 1 Study of MGD010 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: MGD010; Drug: Placebo; Biological: Hepatitis A vaccine

• Registration Number: NCT02376036
• Lead Sponsor: MacroGenics

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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MGD010	MGD010	Subjects will receive MGD010 through IV infusion.
Placebo	Placebo	Subjects will receive placebo through IV infusion.
MGD010 and HepA vaccine	MGD010	Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.
MGD010 and HepA vaccine	Hepatitis A vaccine	Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.
Placebo and HepA vaccine	Placebo	Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.
Placebo and HepA vaccine	Hepatitis A vaccine	Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as assessed by AEs and SAEs	up to Day 57

Secondary Outcome Measures

Name	Time	Method
Serum concentration (pharmacokinetics) of MGD010	up to Day 57
Incidence of MGD010 anti-drug antibodies (ADA)	up to Day 57

Trial Locations

Locations (1)

PAREXEL Baltimore Early Phase Clinical Unit; 🇺🇸 Baltimore, Maryland, United States