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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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 26, 2025 (before its estimated January 29, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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
Trial Details
NCT Number NCT07304791
Lead Sponsor Beam Therapeutics Inc.
Conditions
(from sponsor)		 Healthy Subjects, Healthy Participant Study
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov