Healthy
Conditions
Brief summary
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.
Interventions
DEVICEHarvard Apparatus syringe pump
Used to administer buffer solution with hyaluronic acid SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability Assessment of Subcutaneous Injections Using a Syringe Pump Across Multiple Delivery Parameters | Day 1 | Usability will be assessed by evaluating the proportion of subcutaneous injections administered using Harvard Apparatus syringe pump across varying injection volumes, rates, and needle lengths. |
Countries
United States
Outcome results
None listed