HealthyNCT06516913
A Study of Subcutaneous Injection in Healthy Participants
A study testing Harvard Apparatus syringe pump in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Harvard Apparatus syringe pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 7 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Participant-Blinded Study to Investigate the Effects of Subcutaneous Injection Volume, Injection Rate, and Needle Length on Pain 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.
- Conditions
- Healthy
- Being tested
- Harvard Apparatus syringe pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvard Apparatus syringe pumpDevice
Used to administer buffer solution with hyaluronic acid SC.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (ABHCGDFE) | Experimental | Syringe pump is used to subcutaneously (SC) administer buffer solution with hyaluronic acid as a viscosity agent Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: Harvard Apparatus syringe pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start22 Jul 2024
- Primary completion7 Sep 2024
- Study completion7 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516913
- Sponsor's protocol ID
- 27209
- Other IDs
- J3G-MC-S004
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant-Blinded Study to Investigate the Effects of Subcutaneous Injection Volume, Injection Rate, and Needle Length on Pain in Healthy Participants
- ClinicalTrials.gov ID
- NCT06516913
- Acronym / sponsor ID
- 27209
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 7 Sep 2024 (actual)
- Study completion
- 7 Sep 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (ABHCGDFE) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to subcutaneously (SC) administer buffer solution with hyaluronic acid as a viscosity agent |
| Sequence 2 (BCADHEGF) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
| Sequence 3 (CDBEAFHG) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
| Sequence 4 (DECFBGAH) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
| Sequence 5 (EFDGCHBA) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
| Sequence 6 (FGEHDACB) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
| Sequence 7 (GHFAEBDC) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
| Sequence 8 (HAGBFCED) | Experimental | Device: Harvard Apparatus syringe pumpSyringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harvard Apparatus syringe pumpUsed to administer buffer solution with hyaluronic acid SC. | Device | Sequence 1 (ABHCGDFE), Sequence 2 (BCADHEGF), Sequence 3 (CDBEAFHG), Sequence 4 (DECFBGAH), Sequence 5 (EFDGCHBA), Sequence 6 (FGEHDACB), Sequence 7 (GHFAEBDC), Sequence 8 (HAGBFCED) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvard Apparatus syringe pump in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Assessment of Subcutaneous Injections Using a Syringe Pump Across Multiple Delivery Parameters (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.