Phase 1 Study of MGD010 in Healthy Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: MGD010
* Drug: Placebo
* Biological: Hepatitis A vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGD010<br>Subjects will receive MGD010 through IV infusion. | Drug: MGD010<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Subjects will receive placebo through IV infusion. | Drug: Placebo<br>* Placebo comparator.<br>|
| Experimental: MGD010 and HepA vaccine<br>Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection. | Drug: MGD010<br>* 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.<br>Biological: Hepatitis A vaccine<br>* Hepatitis A vaccine, inactivated<br>* Other names: Vaqta;|
| Placebo Comparator: Placebo and HepA vaccine<br>Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection. | Drug: Placebo<br>* Placebo comparator.<br>Biological: Hepatitis A vaccine<br>* Hepatitis A vaccine, inactivated<br>* Other names: Vaqta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as assessed by AEs and SAEs |  | up to Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration (pharmacokinetics) of MGD010 |  | up to Day 57 | 
| Incidence of MGD010 anti-drug antibodies (ADA) |  | up to Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal healthy volunteer