A Study of Subcutaneous Injection in Healthy Participants
Not Applicable
Not yet recruiting
- Conditions
- Healthy
- Interventions
- Device: Syringe Pump
- Registration Number
- NCT06516913
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The goal of this exploratory study is to learn about the effects of subcutaneous injections on healthy participants.
The study aims to explore how different delivery methods containing a solution impacts injection pain, without an active drug to complicate the results.
Pain assessments will be performed visually and at the injection site to determine the level of pain experienced after each injection.
This study will last approximately 40 days, including screening, assessment, and follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 2 (BCADHEGF) Syringe Pump Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent Sequence 5 (EFDGCHBA) Syringe Pump Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent Sequence 3 (CDBEAFHG) Syringe Pump Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent Sequence 7 (GHFAEBDC) Syringe Pump Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent Sequence 8 (HAGBFCED) Syringe Pump Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent Sequence 1 (ABHCGDFE) Syringe Pump Syringe pump is used to subcutaneously (SC) administer buffer solution with hyaluronic acid as a viscosity agent Sequence 4 (DECFBGAH) Syringe Pump Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent Sequence 6 (FGEHDACB) Syringe Pump Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent
- Primary Outcome Measures
Name Time Method Visual analogue scale (VAS) Pain score at Injection Site Needle insertion to 240 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fortrea CRU, Inc.
🇺🇸Dallas, Texas, United States