A Study of Subcutaneous Injection in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Harvard Apparatus syringe pump

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea CRU, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1 (ABHCGDFE); Syringe pump is used to subcutaneously (SC) administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.
Experimental: Sequence 2 (BCADHEGF); Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.
Experimental: Sequence 3 (CDBEAFHG); Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.
Experimental: Sequence 4 (DECFBGAH); Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.
Experimental: Sequence 5 (EFDGCHBA); Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.
Experimental: Sequence 6 (FGEHDACB); Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.
Experimental: Sequence 7 (GHFAEBDC); Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.
Experimental: Sequence 8 (HAGBFCED); Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent	Device: Harvard Apparatus syringe pump; Used to administer buffer solution with hyaluronic acid SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability Assessment of Subcutaneous Injections Using a Syringe Pump Across Multiple Delivery Parameters	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.	Day 1

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Actual): September 7, 2024
• Study Completion (Actual): September 7, 2024

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 27209; J3G-MC-S004 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No