Actively Recruiting
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
Led by Beam Therapeutics Inc. · Updated on 2025-12-26
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (how the drug affects the body) of BEAM-103, a monoclonal antibody, in healthy adults aged 18 to 55. This Phase 1 study aims to determine the safety and tolerability of BEAM-103, understand its effects on blood parameters, and assess immune responses. The study will help define the appropriate dose ranges for future patient trials. Participants will receive a single intravenous infusion of either BEAM-103 or a placebo (normal saline solution) in ascending dose groups. The study is randomized and single-blind, meaning participants will not know which treatment they receive. Doses will be given through the arm, and the study will monitor effects over time to identify the best dosing strategy. Participants will be involved in the study for about 4 to 5 months, including screening, treatment, and follow-up. They will provide medical history and undergo exams and tests such as blood counts and immune markers at regular intervals. The study will measure safety, blood levels of BEAM-103, and changes in blood cells and proteins. Monitoring will continue for up to 5 months to track any side effects and drug behavior in the body.
CONDITIONS
Brief 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 6514 g/dL for males and 6512 g/dL for females
- Baseline platelet count of >150 �d7 109/L
- General good health without significant medical conditions based on physical exam, ECG, and labs
You will not qualify if you...
- Known hypersensitivity to any component of the investigational medicinal product
- Participation in another clinical trial with an investigational agent within 90 days of consent
- Positive serum pregnancy test or breastfeeding at screening
- Live virus vaccination within 4 weeks prior to consent
- Severe or uncontrolled medical condition that may increase risk or affect study results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up lasting up to 5 months
Participants receive a single intravenous dose of BEAM-103 or placebo to assess safety and pharmacokinetics.
Multiple visits over 5 months for safety and blood sample assessments
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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