NCT06955741已完成1 期
A Phase 1, Randomized, Open-label, Parallel, Single-dose Study to Assess the Pharmacokinetics, Tolerability, and Absolute Bioavailability of Subcutaneous Administration of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Healthy Participants
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年5月5日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
研究概览
简要总结
The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m
- •Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.
排除标准
- •Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
- •Participants must not have prior exposure to BMS-986446 (PRX005).
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm A
Experimental
干预措施: BMS-986446 IV (Drug)
Arm A
Experimental
干预措施: Acetaminophen (Drug)
Arm A
Experimental
干预措施: Loratadine (Drug)
Arm B
Experimental
干预措施: BMS-986446 SC (Drug)
Arm B
Experimental
干预措施: Acetaminophen (Drug)
Arm B
Experimental
干预措施: Loratadine (Drug)
结局指标
主要结局
Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
时间窗: Up to approximately Day 85
Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
时间窗: Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC
时间窗: Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC
时间窗: Up to approximately Day 85
次要结局
- Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to approximately Day 85)
- Number of Participants With Clinically Significant Laboratory Assessment Abnormalities(Up to approximately Day 85)
- Cmax of BMS-986446(Up to approximately Day 85)
- AUC(0-T) of BMS-986446(Up to approximately Day 85)
- AUC(0-672) of BMS-986446(Up to approximately Day 85)
- Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446(Up to approximately Day 85)
- Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446(Up to approximately Day 85)
- Apparent Terminal Serum Half-life (T-HALF) of BMS-986446(Up to approximately Day 85)
- Total Body Clearance in IV Infusion (CLT) of BMS-986446(Up to approximately Day 85)
- Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446(Up to approximately Day 85)
- Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446(Up to approximately Day 85)
- Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446(Up to approximately Day 85)
- Number of Participants With Anti-drug Antibody Development(Up to approximately Day 85)
- Number of Participants With Adverse Events (AEs)(Up to approximately Day 85)
- Number of Participants With Serious Adverse Events (SAEs)(Up to approximately Day 85)
- Number of Participants With AEs Reported Related to BMS-986446(Up to approximately Day 85)
- Number of Participants With Clinically Significant Vital Sign Abnormalities(Up to approximately Day 85)
- Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)(Up to approximately Day 85)
- Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities(Up to approximately Day 85)
- Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire(Up to approximately Day 85)
研究者
研究点 (2)
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