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A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration

2026年8月19日 更新者:Bristol-Myers Squibb

A Phase 1, Open-label, Multi-part Study to Evaluate Pharmacokinetics, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 Following Intravenous and Subcutaneous Administrations in Healthy Adults and Multiple Doses of BMS-986446 in Participants With Early Alzheimer's Disease.

The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration

研究概览

地位

尚未招聘

干预/治疗

研究类型

介入性

注册 (估计的)

84

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:First line of the email MUST contain NCT # and Site #.

研究联系人备份

  • 姓名:BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • 电话号码:855-907-3286
  • 邮箱:Clinical.Trials@bms.com

学习地点

    • California
      • Anaheim、California、美国、92801
        • Local Institution - 0001
        • 接触:
          • Site 0001

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria

  • Participants must have a BMI of 18.0 to 35.0 kg/m2.
  • For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.
  • For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.
  • For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).
  • For Part C: Participants must have evidence of positive plasma pTau217.

Exclusion Criteria

  • For Parts A and B: Participants must not have a general history of any 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.
  • For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.
  • For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.
  • For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Panel A1: BMS986446
指定日期的指定剂量
其他名称:
  • PRX005
  • Moponetug
实验性的:Panel A2: BMS986446
指定日期的指定剂量
其他名称:
  • PRX005
  • Moponetug
实验性的:Panel A3: BMS986446
指定日期的指定剂量
其他名称:
  • PRX005
  • Moponetug
实验性的:Panel B1: BMS986446
指定日期的指定剂量
其他名称:
  • PRX005
  • Moponetug
实验性的:Panel B2: BMS986446
指定日期的指定剂量
其他名称:
  • PRX005
  • Moponetug
实验性的:Panel C1: BMS986446
指定日期的指定剂量
其他名称:
  • PRX005
  • Moponetug

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986446 after subcutaneous (SC) infusion
大体时间:Up to approximately 5 months
Up to approximately 5 months
Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion
大体时间:Up to approximately 5 months
Up to approximately 5 months
Maximum observed concentration (Cmax)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Time of maximum observed concentration (Tmax)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
大体时间:Up to approximately 5 months
Up to approximately 5 months
Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
大体时间:Up to approximately 5 months
Up to approximately 5 months
AUC(INF)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Half-life (T-HALF)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Apparent total body clearance in SC administration (CLT/F)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Total body clearance in IV infusion (CLT)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Volume of distribution of terminal phase (VZ)
大体时间:Up to approximately 5 months
Up to approximately 5 months

次要结果测量

结果测量
措施说明
大体时间
Adverse events (AEs)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Serious adverse events (SAEs)
大体时间:Up to approximately 5 months
Up to approximately 5 months
AEs reported as related to BMS-986446
大体时间:Up to approximately 5 months
Up to approximately 5 months
Incidence of anti-drug antibody (ADA)
大体时间:Up to approximately 5 months
Up to approximately 5 months
Local tolerance evaluation
大体时间:Up to approximately 5 months
This evaluation will assess pain, itching, burning, pressure, and soreness/tenderness (using a Numeric Rating Scale) at the injection site location.
Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for Cmax
大体时间:Up to approximately 5 months
Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)
大体时间:Up to approximately 5 months
Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for Cmax
大体时间:Up to approximately 5 months
Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for AUC
大体时间:Up to approximately 5 months
Up to approximately 5 months
Cmax
大体时间:Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
Tmax
大体时间:Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
AUC(0-T)
大体时间:Up to approximately 5 months
Panel B1, Panel B2
Up to approximately 5 months
AUC(0-672)
大体时间:Up to approximately 5 months
Panel B1, Panel B2
Up to approximately 5 months
AUC(INF)
大体时间:Up to approximately 5 months
Panel B1, Panel B2
Up to approximately 5 months
T-HALF
大体时间:Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
CLT/F
大体时间:Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
Vz/F
大体时间:Up to approximately 5 months
Panel B1, Panel B2, Panel C1
Up to approximately 5 months
Trough observed plasma concentration (Ctrough)
大体时间:Up to approximately 5 months
Panel C1
Up to approximately 5 months
Concentration at the end of a dosing interval (Ctau)
大体时间:Up to approximately 5 months
Panel C1
Up to approximately 5 months
Area under the concentration-time curve within a dosing interval (AUC(TAU))
大体时间:Up to approximately 5 months
Panel C1
Up to approximately 5 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Bristol-Myers Squibb、Bristol-Myers Squibb

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月21日

初级完成 (估计的)

2027年6月17日

研究完成 (估计的)

2027年6月17日

研究注册日期

首次提交

2026年8月19日

首先提交符合 QC 标准的

2026年8月19日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD 共享时间框架

See Plan Description

IPD 共享访问标准

See Plan Description

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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