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:
* Safety and tolerability of BEAM-103 * The pharmacokinetic (PK) profile and pharmacodynamic (PD) characteristics of EAM-103 * The effect of BEAM-103 on hematologic parameters * To assess the immunogenicity of BEAM-103
Researchers will determine and establish the therapeutic window of the antibody and select optimal doses for future trials in patients.
Subjects will:
* Be asked to participate in the study for a duration of 4-5 months total * Be asked to sign informed consent * Be assessed for eligibility * Provide medical and medication history * Receive a single intravenous infusion of BEAM-103 or placebo on study Day 1 according to their assigned cohort * Be followed up to 4 months after infusion
Ages 18 to ≤55 years
Body mass index (BMI) of 18.5 to 25 kg/m2
Morning neutrophil count ≥2.6 × 109 cells/L for Black/African American subjects or ≥3.5 ×109 cells/L for Caucasian/Other subjects
Baseline hemoglobin value of ≥14 g/dL for males and ≥12 g/dL for females
Known hypersensitivity to any component of the investigational medicinal product (IMP).
Participation in another clinical trial involving treatment with an investigational agent within 90 days of informed consent is prohibited.
Positive serum pregnancy test or breastfeeding at screening (female participants).
Live virus vaccination within 4 weeks prior to signing informed consent.
Sequential
BEAM-103
Drug• BEAM-103 is a monoclonal antibody administered as a single intravenous dose
Placebo Comparator
Drug• The matching placebo comparator is administered as a single intravenous dose
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
Change in Free Stem Cell Factor (SCF) in Peripheral Blood Over Time
Concentration of SCF in peripheral blood measured in nanograms per milliliter (mL)
Change in Tryptase Level in Peripheral Blood Over Time
Serum tryptase concentration measured in nanograms per milliliter (ng/mL)
Change in Reticulocyte Count in Peripheral Blood Over Time
Absolute reticulocyte count measured in cells per microliter (cells/µL)
Change in Neutrophil Count in Peripheral Blood Over Time
Absolute neutrophil count measured in cells per microliter (cells/µL)
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