A Randomized, Participant-Blinded Study to Investigate the Effects of Subcutaneous Injection Volume, Injection Rate, and Needle Length on Pain in Healthy Participants

Eli Lilly and Company1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2024年7月22日最近更新: 2025年8月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 32
试验地点: 1
主要终点: Usability Assessment of Subcutaneous Injections Using a Syringe Pump Across Multiple Delivery Parameters

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a device feasibility study designed to evaluate the practicality of delivering a high-viscosity solution subcutaneously using various injection parameters, including volume, rate, and needle length. The goal is to assess the usability and operational performance of a delivery setup (Havard apparatus syringe pump and related components) to inform design requirements for future large-volume injection devices.

No active drug is administered in this study, and no health outcomes are being evaluated.

The study duration is approximately 40 days, including screening, injection assessments, and follow-up.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Device Feasibility
盲法: Single (Participant)

入排标准

年龄范围: 22 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Are healthy as determined by medical evaluation including medical history and physical examination
•Have a waist circumference, measured around umbilicus, of at least 78 centimeters (cm) for participants assigned male at birth, and at least 71 cm for participants assigned female at birth
•Have a BMI within the range of 21.0 to 30.0 kilograms per square meter (kg/m²)
•Participants assigned female at birth must be of non-childbearing potential and must test negative for pregnancy prior to injection on Day 1

排除标准

•Have known allergies to hyaluronic acid, related compounds, or any components of the formulation, or history of significant atopy. Components of the formulation include, but are not limited to, sodium hyaluronate, sodium chloride, and sodium phosphate
•Have a history of severe injection-site reactions
•Have current or previous history of anaphylaxis
•Have tattoos or scars over the abdomen, or other factors, for example excessive folds of skin, that, in the investigator's opinion, would interfere with injection site assessments
•Have self-perceived dullness or loss of sensation on either side of the body and the abdomen
•Have a history or presence of a bleeding, wound healing (including diabetes), or fibrotic disorder
•Have known or ongoing psychiatric disorders