A Randomized, Placebo-Controlled, Ascending Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Parameters of MGTA-145 in Healthy Subjects Administered as a Single Agent, as Well as in Combination With Plerixafor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
研究概览
简要总结
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and in combination with plerixafor.
详细描述
The study consists of up to four parts: Part A, to investigate the safety and tolerability of MGTA-145; Part B, to investigate the safety and tolerability of MGTA-145 when administered in combination with plerixafor; Part C, to investigate the safety and tolerability of two sequential days of dosing MGTA-145 in combination with plerixafor; and Part D, to investigate the safety, tolerability, and measure by apheresis, the total number of CD34+ cells mobilized after a dose of MGTA-145 administered in combination with plerixafor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 18 to 60 years
- •Body weight ≥50 kg and body mass index 19 to 33 kg/m2
- •No clinically significant abnormalities on physical examination at Screening
- •Non-smoker for at least 2 years
- •No clinically significant lab abnormalities for renal, hepatic or hematologic parameters
- •No clinically significant abnormalities on ECG
- •Female subjects must be of non-childbearing potential
- •Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception
- •No contraindications for apheresis
排除标准
- •Any clinically significant laboratory value outside the normal range at screening
- •Donation of more than 500 mL of blood or plasma within 12 weeks prior to dosing
- •History of alcoholism or drug abuse within the past 3 years
- •Subject has used any prescription drugs within 14 days prior to dosing or any dietary supplements or non-prescription drugs within 7 days prior to dosing
- •Acute illness, infection (requiring medical treatment [eg, antibiotics]), or surgery within 4 weeks of dosing
- •Seropositive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus
- •Subject has received another investigational drug or participated in an investigational drug or device study within 12 weeks prior to dosing
- •History of anaphylaxis or clinically important reaction to any drug including plerixafor
- •Any clinically significant hematologic, cardiovascular, pulmonary, central nervous system, metabolic, renal, hepatic, or gastrointestinal conditions
结局指标
主要结局
Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
时间窗: 28 days
Investigate the safety and tolerability of MGTA-145 following intravenous (IV) administration as monotherapy or in combination with plerixafor in healthy subjects (e.g. adverse events, clinical laboratory tests, vital signs, ECGs)
次要结局
- Pharmacokinetics Biomarkers(15 days)
- Pharmacokinetic Biomarkers(15 days)
- Pharmacodynamic Biomarkers(15 days)