A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
2026年7月28日 更新者:GlaxoSmithKline
Open-Label, Randomized, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Two Formulations of GSK5784283 Administered by Subcutaneous Injection
The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic [PK] study) in healthy adults.
The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.
研究概览
研究类型
介入性
注册 (估计的)
24
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:US GSK Clinical Trials Call Center
- 电话号码:877-379-3718
- 邮箱:GSKClinicalSupportHD@gsk.com
研究联系人备份
- 姓名:EU GSK Clinical Trials Call Center
- 电话号码:+44 (0) 20 89904466
- 邮箱:GSKClinicalSupportHD@gsk.com
学习地点
-
-
Texas
-
Austin、Texas、美国、78744
- 招聘中
- GSK Investigational Site
-
接触:
- US GSK Clinical Trials Call Center
- 电话号码:877-379-3718
- 邮箱:GSKClinicalSupportHD@gsk.com
-
接触:
- EU GSK Clinical Trials Call Centre
- 电话号码:+44 (0) 20 8990 4466
- 邮箱:GSKClinicalSupportHD@gsk.com
-
首席研究员:
- Sean Gilbey
-
-
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
接受健康志愿者
是的
描述
Inclusion Criteria:
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Body weight greater than or equal (>=) 50 kilogram (kg) (110 pounds [lbs]) and body mass index within the range 19 to 30 kilogram per meter square (kg/m^2) (inclusive).
- A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
- Hypersensitivity- Participants with allergy/intolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously
- History or presence of any clinically significant medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.
- Current smokers (tobacco and/or marijuana) or former smokers with a smoking history >10 pack-years and participants using vaping products, including electronic cigarettes.
- Regular alcohol consumption that exceeds the limits specified in the protocol
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
- The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read >450 millisecond (msec).
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: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:GSK5784283 Test Formulation
|
将施用 GSK5784283。
|
|
实验性的:GSK5784283 Reference Formulation
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将施用 GSK5784283。
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples
大体时间:Pre-dose and up to 253 days post dose
|
Pre-dose and up to 253 days post dose
|
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Area Under the Curve from Zero up to 253 Days [AUC(0-253 d)] of GSK5784283 Serum Samples
大体时间:Pre-dose and up to 253 days post dose
|
Pre-dose and up to 253 days post dose
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious AEs and Adverse Event of Special Interest (AESI)
大体时间:Up to 253 days
|
Up to 253 days
|
|
Number of Participants with Clinically Significant Change from Baseline in Laboratory Assessments, Vital Signs and Electrocardiogram (ECG) Values
大体时间:Baseline and up to 253 days
|
Baseline and up to 253 days
|
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Proportion of Participants with Anti-drug Antibody (ADA) Incidence, ADA Titre Assessment and Neutralizing Antibody (NAb) Incidence Against GSK5784283
大体时间:Up to 253 days
|
Up to 253 days
|
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:GSK Clinical Trials、GlaxoSmithKline
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 (实际的)
2026年7月17日
初级完成 (估计的)
2027年4月13日
研究完成 (估计的)
2027年4月26日
研究注册日期
首次提交
2026年7月14日
首先提交符合 QC 标准的
2026年7月14日
首次发布 (实际的)
2026年7月17日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 307918
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
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents.
Data sharing is subject to certain criteria, conditions, and exceptions.
For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
IPD 共享时间框架
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
IPD 共享访问标准
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 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.