Phase 1 Study of MGD010 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376036
• Other study ID #: CP-MGD010-01
• Status: Completed
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2022
• Source: MacroGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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.
• Placebo
Placebo comparator.

Biological:
• Hepatitis A vaccine
Hepatitis A vaccine, inactivated

Locations

Country	Name	City	State
United States	PAREXEL Baltimore Early Phase Clinical Unit	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
MacroGenics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability as assessed by AEs and SAEs		up to Day 57
Secondary	Serum concentration (pharmacokinetics) of MGD010		up to Day 57
Secondary	Incidence of MGD010 anti-drug antibodies (ADA)		up to Day 57