A Study to Investigate the Safety and Tolerability of a Wearable On-body Delivery System, and Exploratory Assessment of Participant Response With an Autoinjector, Following Subcutaneous Injections of Placebo in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Device
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given. The study will last up to five weeks for each participant, including a one-week overnight stay in the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy male or female participants as determined by medical history, laboratory tests, physical examination, 12-lead ECGs, and vital signs.
- •Body mass index (BMI) within the range of 18 to 32 kilograms per meter squared (kg/m²)
- •Female participants must not be pregnant, and must test negative for pregnancy
- •Agree to video recording during each administration event using the autoinjector or bolus injector
排除标准
- •Have known allergies to any components of the placebo or related compounds, or history of significant atopy, or known allergies or irritation to adhesives (e.g. skin adhesives, band aid)
- •Have an abnormal blood pressure as determined by the investigator
- •Have a history or presence of a bleeding disorder
- •Have a history of any types of neuropathy, radiculopathy, or fibromyalgia that would affect perception in abdominal wall
- •Have self-perceived dullness or loss-of-sensation on either side of the body or the abdomen
- •Have any condition that could affect pain perception from an injection
- •Have tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection-site assessments
- •Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the trial
- •Are currently using or intend to use painkillers, aspirin, or other nonsteroidal Anti-inflammatory drugs, anticoagulant or antiaggregant drugs, over-the-counter or prescription medication for pain or inflammation
- •Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 2 months or 5 half-lives (whichever is longer) should have passed
- •Are unwilling to stop alcohol consumption
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Are unwilling to abide by the tobacco restrictions
- •Poor peripheral venous access
- •Have a pacemaker and/or similar devices/other implantables
研究组 & 干预措施
On-Body Delivery System (OBDS)/Multiple Bolus Injector
On-Body Delivery System (OBDS)/Multiple bolus injector used to administer placebo subcutaneously (SC).
干预措施: On-Body Delivery System (OBDS)/Multiple Bolus Injector (Device)
On-Body Delivery System (OBDS)/Multiple Bolus Injector
On-Body Delivery System (OBDS)/Multiple bolus injector used to administer placebo subcutaneously (SC).
干预措施: Placebo (Drug)
Single Auto Injector
Single auto injector used to administer placebo SC.
干预措施: Single Auto Injector (Device)
Single Auto Injector
Single auto injector used to administer placebo SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Device
时间窗: Baseline through day 7
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
未报告次要终点