A Study of Subcutaneous Injection in Healthy Participants

NCT06516913 | Completed FDA Device

• 2 other identifiers: 27209J3G-MC-S004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (8)

Sequence 1 (ABHCGDFE)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Sequence 2 (BCADHEGF)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Sequence 3 (CDBEAFHG)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Sequence 4 (DECFBGAH)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Sequence 5 (EFDGCHBA)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Sequence 6 (FGEHDACB)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Sequence 7 (GHFAEBDC)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Sequence 8 (HAGBFCED)

EXPERIMENTAL

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

Device: Harvard Apparatus syringe pump

Interventions

Harvard Apparatus syringe pump DEVICE

Used to administer buffer solution with hyaluronic acid SC.

Sequence 1 (ABHCGDFE); Sequence 2 (BCADHEGF); Sequence 3 (CDBEAFHG); Sequence 4 (DECFBGAH); Sequence 5 (EFDGCHBA); Sequence 6 (FGEHDACB); Sequence 7 (GHFAEBDC); Sequence 8 (HAGBFCED)

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea CRU, Inc.

Dallas, Texas, 75247, United States

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 22, 2024
• Primary Completion: September 7, 2024
• Study Completion: September 7, 2024
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)