Status:
COMPLETED
A Study of Subcutaneous Injection in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
22-75 years
Phase:
NA
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06516913
Start Date
July 22 2024
End Date
September 7 2024
Last Update
August 27 2025
Active Locations (1)
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1
Fortrea CRU, Inc.
Dallas, Texas, United States, 75247