A Study of Subcutaneous Injection in Healthy Participants

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT06516913

Run by

Eli Lilly and Company

People needed

32

Starts

2024-07-22

Expected to finish

2024-09-07

Last updated by the study team

2025-08-27

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fortrea CRU, Inc. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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