Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose of MGTA-145 or placebo | Placebo Comparator | MGTA-145 or placebo dose escalation as single agent, single dose |
|
| Single Dose MGTA-145 or placebo plus plerixafor | Placebo Comparator | MGTA-145 or placebo in combination with plerixafor, single dose |
|
| Single dose MGTA-145 plus plerixafor for 2 sequential d | Experimental | MGTA-145 in combination with plerixafor on two consecutive days; single dose per day |
|
| Single dose MGTA-145 plus plerixafor followed by apheresis | Experimental | MGTA-145 in combination with plerixafor followed by apheresis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGTA-145 | Biological | MGTA-145 will be given in various doses intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Biomarkers | Investigate area under the curve (AUC) of MGTA-145 | 15 days |
| Pharmacokinetics Biomarkers | Investigate maximum plasma concentration (Cmax) of MGTA-145 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace CPU | Cincinnati | Ohio | 45227 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double Blind
| plerixafor | Biological | 240 µg/kg subcutaneously |
|
|
| Placebo | Biological | Placebo will be given in various doses intravenously |
|
| 15 days |
| Pharmacokinetic Biomarkers | Investigate clearance (CL) of MGTA-145 | 15 days |
| Pharmacokinetic Biomarkers | Investigate the volume of distribution at steady state (Vdss) of MGTA-145 | 15 days |
| Pharmacokinetic Biomarkers | Investigate the half-life of MGTA-145 | 15 days |
| Pharmacodynamic Biomarkers | Assess CD34+ cells per uL of blood by flow cytometry | 15 days |
| Pharmacodynamic Biomarkers | Assess stem cell progenitors (colony forming units) | 15 days |
| ID | Term |
|---|---|
| C088327 | plerixafor |
Not provided
Not provided
Not provided