Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07304791 | This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of BEAM-103 in Healthy Subjects | PHASE1 | RECRUITING | 30 | — | — | Oct 27, 2025 | May 29, 2026 | Dec 26, 2025 | 1 | United Kingdom |
Incidence of treatment-emergent AEs, serious AEs, severe AEs, AEs related to BEAM-103
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
Inclusion Criteria: * 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 * Bas...