Actively Recruiting
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
Led by Beam Therapeutics Inc. · Updated on 2025-12-26
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 65 years
- Body mass index (BMI) of 18.5 to 25 kg/m2
- Morning neutrophil count 62.6 �d7 109 cells/L for Black/African American subjects or 63.5 �d7 109 cells/L for Caucasian/Other subjects
- Baseline hemoglobin value of 614 g/dL for males and 612 g/dL for females
- Baseline platelet count of >150 �d7 109/L
- Subjects must be in general good health without significant medical conditions (based on physical exam, ECG, and laboratory test results with no clinically significant deviations), per the investigator's assessment
You will not qualify if you...
- Known hypersensitivity to any component of the investigational medicinal product
- Participation in another clinical trial involving treatment with an investigational agent within 90 days of informed consent
- 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 would put the subject at undue medical risk or impair the ability to interpret study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Study Site
London, United Kingdom
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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