A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
A Phase 1, Open-Label, Randomized, Single-Dose Study to Evaluate the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of pegozafermin administered in the abdomen, thigh, or upper arm in healthy participants.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名:Reference Study ID Number: GP46978 https://forpatients.roche.com/ No attachments to email below
- 电话号码:888-662-6728 (U.S. and Canada)
- 邮箱:global-roche-genentech-trials@gene.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants with a body mass index (BMI) within the range of 18.5-35.0 kilogram per square meter (kg/m²)
- Participants in good health, as determined by medical history, physical examination findings, vital signs, electrocardiogram (ECG), and clinical laboratory tests at screening and prior to dosing
- Participants with willingness and ability to comply with all study requirements
Exclusion Criteria:
- Participants with a history of pancreatitis or gallbladder/biliary disorders (including cholelithiasis or cholecystitis), clinically significant menstrual abnormalities per investigator judgment, or hypertension
- Participants with known hypersensitivity to pegozafermin or its excipients or history of severe allergic or hypersensitivity reactions that may place the participant at risk
- Participants with any abnormality of the skin such as tattoo(s) or scarring or SC tissue at or near potential injection sites that may interfere with administration or assessment of the injection
- Participants with any history of malignancy
- Participants who are pregnant, breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required
- Participants with a positive result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies or p24 antigen at screening
- Participants with significant alcohol consumption, defined as > 14 units/week for females or > 21 units/week for males
- Participants with a history of recent (i.e., 6 months) bone trauma, fracture, or surgery or other clinically significant bone-related conditions
- Participants with poor peripheral venous access
Note: Other protocol-defined inclusion/exclusion criteria may apply.
学习计划
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: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:Group A
Participants will receive pegozafermin as per the schedule specified in the protocol in the abdomen. |
Pergozafermin will be administered as specified in the protocol. |
|
实验性的:Group B
Participants will receive pegozafermin as per the schedule specified in the protocol in the thigh. |
Pergozafermin will be administered as specified in the protocol. |
|
实验性的:Group C
Participants will receive pegozafermin as per the schedule specified in the protocol in the upper arm. |
Pergozafermin will be administered as specified in the protocol. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Pegozafermin
大体时间:From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUClast) of Pegozafermin
大体时间:From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Area Under the Serum Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Pegozafermin
大体时间:From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Relative Bioavailability (Frel) of Pegozafermin for Thigh Versus Abdomen
大体时间:Up to Day 22
|
Up to Day 22
|
|
Frel of Pegozafermin for Upper Arm Versus Abdomen
大体时间:Up to Day 22
|
Up to Day 22
|
|
Time of Maximum Observed Serum Concentration (Tmax) of Pegozafermin
大体时间:From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Terminal Elimination Half-Life (t1/2) of Pegozafermin
大体时间:From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Apparent Systemic Clearance (CL/F) of Pegozafermin
大体时间:From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Apparent Volume of Distribution (Vz/F) of Pegozafermin
大体时间:From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
大体时间:Up to approximately 50 days
|
Up to approximately 50 days
|
|
Number of Participants With Injection Site Reactions (ISRs)
大体时间:Up to 24 hours post-dose on Day 1
|
Up to 24 hours post-dose on Day 1
|
合作者和调查者
调查人员
- 研究主任:Clinical Trials、Hoffmann-La Roche
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- GP46978
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.