NCT07304791招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of single ascending doses of BEAM-103
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
BEAM-103 Drug Product
Experimental
BEAM-103 is a monoclonal antibody that will be administered in single dose ascending dose cohorts as an intravenous infusion through the arm.
干预措施: BEAM-103 (Drug)
Placebo
Placebo Comparator
Normal Saline Solution will be administered as a matching place in single dose ascending dose cohorts as an intravenous infusion through the arm.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
To determine the safety and tolerability of single ascending doses of BEAM-103
时间窗: from enrollment to the end of study at 5 months
Incidence of treatment-emergent AEs, serious AEs, severe AEs, AEs related to BEAM-103
次要结局
- Change in Free Stem Cell Factor (SCF) in Peripheral Blood Over Time(from the start of treatment to the end of study at 5 months)
- Change in Tryptase Level in Peripheral Blood Over Time(from the start of treatment to the end of study at 5 months)
- Change in Reticulocyte Count in Peripheral Blood Over Time(From enrollment to end of study at 5 months)
- Change in Neutrophil Count in Peripheral Blood Over Time(From enrollment to end of study at 5 months)
- Maximum Observed Plasma Concentration (Cmax)(From enrollment to end of study at 5 months)
- Area Under the Plasma Concentration-Time Curve to Last Quantifiable Concentration (AUClast)(From enrollment to end of study at 5 months)
- Area Under the Plasma Concentration-Time Curve to Infinity (AUC∞)(From enrollment to end of study at 5 months)
- Terminal Elimination Half-Life (t½)(From enrollment to end of study at 5 months)
研究者
研究点 (1)
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