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Clinical Trials in the UK / NCT07304791
Recruiting Phase 1

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

NCT07304791 · tracked via the Priya Life Science UK tracker
Sponsor
Beam Therapeutics Inc
Phase
Phase 1
Started
2025-10-27
Last updated
2025-12-26

Condition(s) studied

Healthy SubjectsHealthy Participant Study

Investigational drug(s) / intervention(s)

BEAM-103Placebo Comparator

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

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

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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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: * 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.

Primary outcome measure(s)

  • To determine the safety and tolerability of single ascending doses of BEAM-103 — from enrollment to the end of study at 5 months
    Incidence of treatment-emergent AEs, serious AEs, severe AEs, AEs related to BEAM-103

Trial sites (1)

FacilityCityRegionStatus
Clinical Study Site London United Kingdom Recruiting

More Beam Therapeutics Inc. trials in the UK

A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07304791 on ClinicalTrials.gov ↗ ← All trials in the UK