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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- MacroGenics
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Safety and Tolerability as assessed by AEs and SAEs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 50 years of age
- •Body mass index (BMI) of 18 to 30 kg/m2, inclusive
排除标准
- •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
研究组 & 干预措施
MGD010
Subjects will receive MGD010 through IV infusion.
干预措施: MGD010 (Drug)
Placebo
Subjects will receive placebo through IV infusion.
干预措施: Placebo (Drug)
MGD010 and HepA vaccine
Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.
干预措施: MGD010 (Drug)
MGD010 and HepA vaccine
Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection.
干预措施: Hepatitis A vaccine (Biological)
Placebo and HepA vaccine
Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.
干预措施: Placebo (Drug)
Placebo and HepA vaccine
Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection.
干预措施: Hepatitis A vaccine (Biological)
结局指标
主要结局
Safety and Tolerability as assessed by AEs and SAEs
时间窗: up to Day 57
次要结局
- Serum concentration (pharmacokinetics) of MGD010(up to Day 57)
- Incidence of MGD010 anti-drug antibodies (ADA)(up to Day 57)