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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02376036

Enrollment

Registered

2015-03-03

Start date

2015-02-28

Completion date

2017-02-28

Last updated

2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Normal healthy volunteer

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.

Interventions

DRUGMGD010

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.

DRUGPlacebo

Placebo comparator.

BIOLOGICALHepatitis A vaccine

Hepatitis A vaccine, inactivated

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability as assessed by AEs and SAEs	up to Day 57

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026