NCT07712393招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples
研究概览
简要总结
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
GSK5784283 Reference Formulation
Experimental
干预措施: GSK5784283 (Drug)
GSK5784283 Test Formulation
Experimental
干预措施: GSK5784283 (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples
时间窗: Pre-dose and up to 253 days post dose
Area Under the Curve from Zero up to 253 Days [AUC(0-253 d)] of GSK5784283 Serum Samples
时间窗: Pre-dose and up to 253 days post dose
次要结局
- Proportion of Participants with Anti-drug Antibody (ADA) Incidence, ADA Titre Assessment and Neutralizing Antibody (NAb) Incidence Against GSK5784283(Up to 253 days)
- Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious AEs and Adverse Event of Special Interest (AESI)(Up to 253 days)
- Number of Participants with Clinically Significant Change from Baseline in Laboratory Assessments, Vital Signs and Electrocardiogram (ECG) Values(Baseline and up to 253 days)
研究者
研究点 (1)
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