A Study of Subcutaneous Injection in Healthy Participants
NCT06516913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-08-27
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
Interventions
- DEVICE
-
Harvard Apparatus syringe pump
Used to administer buffer solution with hyaluronic acid SC.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
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 Design
- Allocation
- RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 22 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-22
- Primary Completion
- 2024-09-07
- Completion
- 2024-09-07
- FDA Device
- Yes
Countries
- United States
Study Locations
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