A Study of Subcutaneous Injection in Healthy Participants

August 20, 2025 updated by: Eli Lilly and Company

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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