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RecruitingNCT07304791Updated Dec 26, 2025

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 Phase 1 interventional study of BEAM-103 and Placebo Comparator in Healthy Subjects and Healthy Participant Study, sponsored by Beam Therapeutics Inc.. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Beam Therapeutics Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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
02

Conditions studied

  • Healthy Subjects
  • Healthy Participant Study

Keywords

  • ESCAPE
  • BEAM-103
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • 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 criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    BEAM-103 Drug Product

    BEAM-103 is a monoclonal antibody that will be administered in single dose ascending dose cohorts as an intravenous infusion through the arm.

    Drug: BEAM-103

  • Placebo comparator
    Placebo

    Normal Saline Solution will be administered as a matching place in single dose ascending dose cohorts as an intravenous infusion through the arm.

    Drug: Placebo Comparator

Interventions

  • DrugBEAM-103

    • BEAM-103 is a monoclonal antibody administered as a single intravenous dose

  • DrugPlacebo Comparator

    • The matching placebo comparator is administered as a single intravenous dose

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: from enrollment to the end of study at 5 months

Secondary outcomes

  1. Change in Free Stem Cell Factor (SCF) in Peripheral Blood Over Time

    Concentration of SCF in peripheral blood measured in nanograms per milliliter (mL)

    Time frame: from the start of treatment to the end of study at 5 months

  2. Change in Tryptase Level in Peripheral Blood Over Time

    Serum tryptase concentration measured in nanograms per milliliter (ng/mL)

    Time frame: from the start of treatment to the end of study at 5 months

  3. Change in Reticulocyte Count in Peripheral Blood Over Time

    Absolute reticulocyte count measured in cells per microliter (cells/µL)

    Time frame: From enrollment to end of study at 5 months

  4. Change in Neutrophil Count in Peripheral Blood Over Time

    Absolute neutrophil count measured in cells per microliter (cells/µL)

    Time frame: From enrollment to end of study at 5 months

  5. Maximum Observed Plasma Concentration (Cmax)

    Cmax will be calculated as the highest observed plasma/blood/serum concentration following drug administration

    Time frame: From enrollment to end of study at 5 months

  6. Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)

    AUClast will be calculated from time zero to the time of the last quantifiable concentration

    Time frame: From enrollment to end of study at 5 months

  7. Area Under the Plasma Concentration-Time Curve to Infinity (AUC∞)

    AUC∞ will be calculated as AUClast plus Clast divided by λz

    Time frame: From enrollment to end of study at 5 months

  8. Terminal Elimination Half-Life (t½)

    t½ will be estimated from the terminal elimination phase of the plasma concentration-time curve

    Time frame: From enrollment to end of study at 5 months

06

Study locations

1 of 1 sites recruiting
  • Clinical Study Site
    London, United Kingdom
    Recruiting
07

Registry details

Key details

Study ID
NCT07304791
Lead sponsor
Beam Therapeutics Inc.
Responsible party
Sponsor
First posted
Dec 26, 2025
Start date
Oct 27, 2025
Primary completion
Jan 29, 2026 (estimated)
Completion
May 29, 2026 (estimated)
Last update
Dec 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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