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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

NCT07304791 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-26

No results posted yet for this 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

Conditions

  • Healthy Subjects
  • Healthy Participant Study

Interventions

DRUG

BEAM-103

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

DRUG

Placebo Comparator

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

Sponsors & Collaborators

  • Beam Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2026-01-29
Completion
2026-05-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304791 on ClinicalTrials.gov