RecruitingPhase 1NCT07304791

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

A Randomized, Single-Blind, Placebo-Controlled, Phase 1 Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BEAM-103 in Healthy Subjects

Sponsor

Beam Therapeutics Inc.

Enrollment

30 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Subjects Healthy Participant Study

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

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
Baseline platelet count of >150 × 109/L.
Subjects must be in general good health without significant medical conditions (based on physical exam, electrocardiogram (ECG), and laboratory test results with no clinically significant deviations), per the investigator's assessment

Exclusion Criteria5

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.
Any severe or uncontrolled medical condition (eg. severe asthma or severe peanut allergy) that in the opinion of the investigator would put the subject at undue medical risk or impair the ability to interpret study results.

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