Phase 1 randomized single‑blind placebo‑controlled safety and dosing of BEAM‑103 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single ascending dose, randomized, single‑blind, placebo‑controlled trial in healthy volunteers that will administer a single IV infusion of BEAM‑103 or placebo and follow participants for up to four months. The trial will collect safety data, pharmacokinetics (how the drug is absorbed, distributed, metabolized, and cleared), pharmacodynamics (biologic effects), hematologic measures, and immunogenicity (antibody responses to the drug). Participants will be screened for normal labs and general good health and must meet narrow BMI and blood count criteria before enrollment. Results will be used to define a therapeutic window and select doses for future patient trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Study Site
  London, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.