此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study to Investigate the Effect of Injection Site and Ethnicity on KAI-4729 Pharmacokinetics in Non-Asian and Asian Participants Living With Obesity or Overweight

2026年11月3日 更新者:Kailera

A Phase 1, Randomized, Open-Label, Single-Dose Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-4729 Subcutaneous Injection and Pharmacokinetics of KAI-4729 in Non-Asian and Asian Participants Living With Obesity or Overweight

The main objectives of this study are to assess the relative bioavailability of KAI-4729 subcutaneous (SC) injection in the upper arm and thigh compared with the abdomen and to measure the pharmacokinetics of KAI-4729 in plasma following a single SC dose in healthy non-Asian and Asian participants.

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)

60

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

学习地点

    • California
      • Anaheim、California、美国、92801
        • Kailera Clinical Site

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

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • Have a body mass index (BMI) ≥25 and ≤40 kilograms per square meter at screening (Days -28 to -2) and on Day -1 of the first Treatment Period
  • Non-Asian Participants Only: Be of non-Asian descent and not identify as being of East Asian origin
  • Asian Participants Only: Be of Asian descent, identify as being of East Asian origin, and have both parents and both sets of grandparents born in East Asia and of East Asian descent
  • Medically healthy

Key Exclusion Criteria:

  • Have estimated glomerular filtration rate <60 milliliters/minute/1.73 square meters at screening (Days -28 to -2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration calculation.
  • Have hemoglobin A1c test result ≥6.5% or blood glucose ≥126 milligrams/deciliter (≥7 millimoles/liter) at screening (Days -28 to -2).
  • Have a history of, or positive test results at screening (Days -28 to -2) for, human immunodeficiency virus (HIV), hepatitis B surface antigen, or active hepatitis C virus infection.
  • Have positive drugs of abuse or alcohol test results at screening (Days -28 to -2) or on Day -1 of each Treatment Period.
  • Be pregnant or planning to be pregnant and/or breastfeeding or planning to breastfeed during the study and within 5 half-lives of the study drug (25 days) following the last study treatment dose.
  • Have any history of malignant disease, including in situ cervical or prostate cancer, within the 5 years prior to informed consent (excludes basal or squamous cell carcinoma that was successfully treated).
  • Have history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the 3 months prior to informed consent determined by the Investigator (or delegate) to be clinically relevant.
  • Have known hypersensitivity to the study drug; glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide, and/or glucagon receptor agonist therapies; or any of the study drug ingredients.
  • Have any other conditions or received prior therapy that, in the opinion of the Investigator (or delegate), would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 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:Upper Arm Injection Site

Participants will receive KAI-4729 as a single SC injection into the upper arm on Day 1 of either Treatment Period 1, 2, or 3.

SC injection

实验性的:Abdomen Injection Site

Participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of either Treatment Period 1, 2, or 3.

SC injection

实验性的:Thigh Injection Site

Participants will receive KAI-4729 as a single SC injection into the thigh on Day 1 of either Treatment Period 1, 2, or 3.

SC injection

实验性的:Abdomen Injection Site (Asian Participants)

Asian participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of Treatment Period 1.

SC injection

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Maximum Observed Plasma Concentration (Cmax) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
大体时间:Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
大体时间:Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
大体时间:Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Cmax of KAI-4729 in Healthy Non-Asian and Asian Participants
大体时间:Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
AUC0-t of KAI-4729 in Healthy Non-Asian and Asian Participants
大体时间:Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
AUC0-inf of KAI-4729 in Healthy Non-Asian and Asian Participants
大体时间:Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)

次要结果测量

结果测量
大体时间
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
大体时间:Day 1 to Day 99
Day 1 to Day 99
Number of Participants Who Experience a Serious Adverse Event (SAE)
大体时间:Day 1 to Day 99
Day 1 to Day 99
Number of Participants Who Experience Antidrug Antibodies (ADAs) to KAI-4729
大体时间:Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose

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。

赞助

调查人员

  • 研究主任:Medical Director、Kailera Therapeutics, Inc.

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11月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年11月3日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11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)?

不

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.

订阅