At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BEAM-103 (drug), Placebo Comparator (drug)
- How long the study runs
- Study runs about 7 months (dates as stated)
- About the drug or intervention
- BEAM-103 — drug: • BEAM-103 is a monoclonal antibody administered as a single intravenous dose · Placebo Comparator — drug: • The matching placebo comparator is administered as a single intravenous dose
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 55 Years
- Who
- All
- Number of participants
- 30
- Started
- 2025-10-27
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for healthy subjects
- • Phase1 - 30 participants
- • 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
Who can take part?
- • Ages 18 Years to 55 Years
- • Diagnosed with healthy subjects
Where?
- • London - Clinical Study Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 55 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓Baseline red blood cell level value of ≥14 g/dL for males and ≥12 g/dL for females
- ✓Baseline blood clotting cell count of \>150 × 109/L.
Who cannot take part
- ✗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...
- ✗Positive serum pregnancy test or breastfeeding at screening (female participants).
- ✗Live virus vaccination within 4 weeks prior to signing agreement to take part.
See the full criteria
Where Is This Study? (1 UK site)
Clinical Study Site
London, United Kingdom