To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
MGTA-145 will be given in various doses intravenously
240 µg/kg subcutaneously
Placebo will be given in various doses intravenously
Medpace CPU
Cincinnati, Ohio, United States
Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
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)
Time frame: 28 days
Pharmacokinetics Biomarkers
Investigate area under the curve (AUC) of MGTA-145
Time frame: 15 days
Pharmacokinetics Biomarkers
Investigate maximum plasma concentration (Cmax) of MGTA-145
Time frame: 15 days
Pharmacokinetic Biomarkers
Investigate clearance (CL) of MGTA-145
Time frame: 15 days
Pharmacokinetic Biomarkers
Investigate the volume of distribution at steady state (Vdss) of MGTA-145
Time frame: 15 days
Pharmacokinetic Biomarkers
Investigate the half-life of MGTA-145
Time frame: 15 days
Pharmacodynamic Biomarkers
Assess CD34+ cells per uL of blood by flow cytometry
Time frame: 15 days
Pharmacodynamic Biomarkers
Assess stem cell progenitors (colony forming units)
Time frame: 15 days
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