Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor

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.

Inclusion criteria

• 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

Exclusion criteria

• 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