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OpenTrials
Completed

NCT Number: NCT06516913

A Study of Subcutaneous Injection 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.

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Key information

Conditions

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fortrea CRU, Inc.

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Harvard Apparatus syringe pump

Device

Used to administer buffer solution with hyaluronic acid SC.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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