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Recruiting NCT07304791

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

Phase I Interventional Healthy Subjects Healthy Participant Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BEAM-103, Placebo Comparator.
Who it may be relevant to
Registry conditions: Healthy Subjects, Healthy Participant Study. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • To determine the safety and tolerability of single ascending doses of BEAM-103 [Time frame: from enrollment to the end of study at 5 months]
Secondary outcome measures (8)
  • Change in Free Stem Cell Factor (SCF) in Peripheral Blood Over Time [Time frame: from the start of treatment to the end of study at 5 months]
  • Change in Tryptase Level in Peripheral Blood Over Time [Time frame: from the start of treatment to the end of study at 5 months]
  • Change in Reticulocyte Count in Peripheral Blood Over Time [Time frame: From enrollment to end of study at 5 months]
  • Change in Neutrophil Count in Peripheral Blood Over Time [Time frame: From enrollment to end of study at 5 months]
  • Maximum Observed Plasma Concentration (Cmax) [Time frame: From enrollment to end of study at 5 months]
  • Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast) [Time frame: From enrollment to end of study at 5 months]
  • Area Under the Plasma Concentration-Time Curve to Infinity (AUC∞) [Time frame: From enrollment to end of study at 5 months]
  • Terminal Elimination Half-Life (t½) [Time frame: From enrollment to end of study at 5 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Basic science

Study locations

United Kingdom · 1 center
  • Clinical Study Site — London

Identifiers

NCT: NCT07304791 · BTX-103-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗