A Study of Subcutaneous Injection in Healthy Participants

Lilly

Status: Completed

Conditions: Healthy

Treatments: Device: Harvard Apparatus syringe pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT06516913

27209

J3G-MC-S004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 8 patient groups

Sequence 1 (ABHCGDFE)

Experimental group

Description:

Syringe pump is used to subcutaneously (SC) administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump

Sequence 2 (BCADHEGF)

Experimental group

Description:

Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump

Sequence 3 (CDBEAFHG)

Experimental group

Description:

Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump

Sequence 4 (DECFBGAH)

Experimental group

Description:

Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump

Sequence 5 (EFDGCHBA)

Experimental group

Description:

Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump

Sequence 6 (FGEHDACB)

Experimental group

Description:

Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump

Sequence 7 (GHFAEBDC)

Experimental group

Description:

Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump

Sequence 8 (HAGBFCED)

Experimental group

Description:

Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent

Treatment:

Device: Harvard Apparatus syringe pump