A Study of Subcutaneous Injection in Healthy Participants

NCT ID: NCT06516913

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2024-09-07

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Sequence 1 (ABHCGDFE)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 2 (BCADHEGF)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 3 (CDBEAFHG)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 4 (DECFBGAH)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 5 (EFDGCHBA)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 6 (FGEHDACB)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 7 (GHFAEBDC)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 8 (HAGBFCED)

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

Group Type: EXPERIMENTAL

Harvard Apparatus syringe pump

Intervention Type: DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Interventions

Harvard Apparatus syringe pump

Used to administer buffer solution with hyaluronic acid SC.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Fortrea CRU, Inc.

Dallas, Texas, United States

Countries

United States

Other Identifiers

J3G-MC-S004

Identifier Type: OTHER

Identifier Source: secondary_id

27209

Identifier Type: -

Identifier Source: org_study_id