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The purpose of this Phase I single ascending dose study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of BEAM-103 in healthy subjects between the ages of 18 and 55. The main questions the study aims to answer are:
Researchers will determine and establish the therapeutic window of the antibody and select optimal doses for future trials in patients.
Subjects will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEAM-103 Drug Product | Experimental | BEAM-103 is a monoclonal antibody that will be administered in single dose ascending dose cohorts as an intravenous infusion through the arm. |
|
| Placebo | Placebo Comparator | Normal Saline Solution will be administered as a matching place in single dose ascending dose cohorts as an intravenous infusion through the arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEAM-103 | Drug | • BEAM-103 is a monoclonal antibody administered as a single intravenous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of single ascending doses of BEAM-103 | Incidence of treatment-emergent AEs, serious AEs, severe AEs, AEs related to BEAM-103 | from enrollment to the end of study at 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Free Stem Cell Factor (SCF) in Peripheral Blood Over Time | Concentration of SCF in peripheral blood measured in nanograms per milliliter (mL) | from the start of treatment to the end of study at 5 months |
| Change in Tryptase Level in Peripheral Blood Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Recruiting | London | United Kingdom |
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| Placebo Comparator | Drug | • The matching placebo comparator is administered as a single intravenous dose |
|
Serum tryptase concentration measured in nanograms per milliliter (ng/mL) |
| from the start of treatment to the end of study at 5 months |
| Change in Reticulocyte Count in Peripheral Blood Over Time | Absolute reticulocyte count measured in cells per microliter (cells/µL) | From enrollment to end of study at 5 months |
| Change in Neutrophil Count in Peripheral Blood Over Time | Absolute neutrophil count measured in cells per microliter (cells/µL) | From enrollment to end of study at 5 months |
| Maximum Observed Plasma Concentration (Cmax) | Cmax will be calculated as the highest observed plasma/blood/serum concentration following drug administration | From enrollment to end of study at 5 months |
| Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast) | AUClast will be calculated from time zero to the time of the last quantifiable concentration | From enrollment to end of study at 5 months |
| Area Under the Plasma Concentration-Time Curve to Infinity (AUC∞) | AUC∞ will be calculated as AUClast plus Clast divided by λz | From enrollment to end of study at 5 months |
| Terminal Elimination Half-Life (t½) | t½ will be estimated from the terminal elimination phase of the plasma concentration-time curve | From enrollment to end of study at 5 months |