HealthyPhase 1NCT04848402
A Device Study in Healthy Participants
A Phase 1 study testing On-Body Delivery System (OBDS)/Multiple Bolus Injector and Single Auto Injector in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- On-Body Delivery System (OBDS)/Multiple Bolus Injector and Single Auto Injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2021to 22 Jul 2022
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy male or female participants as determined by medical history, laboratory tests, physical examination, 12-lead ECGs, and vital signs.
- Body mass index (BMI) within the range of 18 to 32 kilograms per meter squared (kg/m²)
- Female participants must not be pregnant, and must test negative for pregnancy
- Agree to video recording during each administration event using the autoinjector or bolus injector
Who cannot join
- Have known allergies to any components of the placebo or related compounds, or history of significant atopy, or known allergies or irritation to adhesives (e.g. skin adhesives, band aid)
- Have an abnormal blood pressure as determined by the investigator
- Have a history or presence of a bleeding disorder
- Have a history of any types of neuropathy, radiculopathy, or fibromyalgia that would affect perception in abdominal wall
- Have self-perceived dullness or loss-of-sensation on either side of the body or the abdomen
- Have any condition that could affect pain perception from an injection
Show all 15Show fewer
- Have tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection-site assessments
- Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the trial
- Are currently using or intend to use painkillers, aspirin, or other nonsteroidal Anti-inflammatory drugs, anticoagulant or antiaggregant drugs, over-the-counter or prescription medication for pain or inflammation
- Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 2 months or 5 half-lives (whichever is longer) should have passed
- Are unwilling to stop alcohol consumption
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Are unwilling to abide by the tobacco restrictions
- Poor peripheral venous access
- Have a pacemaker and/or similar devices/other implantables
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Safety and Tolerability of a Wearable On-body Delivery System, and Exploratory Assessment of Participant Response With an Autoinjector, Following Subcutaneous Injections of Placebo in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given. The study will last up to five weeks for each participant, including a one-week overnight stay in the study center.
- Conditions
- Healthy
- Being tested
- On-Body Delivery System (OBDS)/Multiple Bolus Injector, Single Auto Injector, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-Body Delivery System (OBDS)/Multiple Bolus InjectorDevice
Used to administer placebo SC.
Single Auto InjectorDevice
Used to administer placebo SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| On-Body Delivery System (OBDS)/Multiple Bolus Injector | Experimental | On-Body Delivery System (OBDS)/Multiple bolus injector used to administer placebo subcutaneously (SC). Receives: Device: On-Body Delivery System (OBDS)/Multiple Bolus Injector; Drug: Placebo |
| Single Auto Injector | Experimental | Single auto injector used to administer placebo SC. Receives: Device: Single Auto Injector; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Device
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start27 Sep 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT04848402
- Sponsor's protocol ID
- 17770
- Other IDs
- H7K-MC-O005
- Status last verified
- Feb 2023
- First submitted
- 16 Apr 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety and Tolerability of a Wearable On-body Delivery System, and Exploratory Assessment of Participant Response With an Autoinjector, Following Subcutaneous Injections of Placebo in Healthy Participants
- ClinicalTrials.gov ID
- NCT04848402
- Acronym / sponsor ID
- 17770
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 19 Apr 2021 (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.
The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given. The study will last up to five weeks for each participant, including a one-week overnight stay in the study center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-Body Delivery System (OBDS)/Multiple Bolus Injector | Experimental | Device: On-Body Delivery System (OBDS)/Multiple Bolus Injector, Drug: PlaceboOn-Body Delivery System (OBDS)/Multiple bolus injector used to administer placebo subcutaneously (SC). |
| Single Auto Injector | Experimental | Device: Single Auto Injector, Drug: PlaceboSingle auto injector used to administer placebo SC. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overtly healthy male or female participants as determined by medical history, laboratory tests, physical examination, 12-lead ECGs, and vital signs.
- Body mass index (BMI) within the range of 18 to 32 kilograms per meter squared (kg/m²)
- Female participants must not be pregnant, and must test negative for pregnancy
- Agree to video recording during each administration event using the autoinjector or bolus injector
Key exclusion criteria (15 listed)
- Have known allergies to any components of the placebo or related compounds, or history of significant atopy, or known allergies or irritation to adhesives (e.g. skin adhesives, band aid)
- Have an abnormal blood pressure as determined by the investigator
- Have a history or presence of a bleeding disorder
- Have a history of any types of neuropathy, radiculopathy, or fibromyalgia that would affect perception in abdominal wall
- Have self-perceived dullness or loss-of-sensation on either side of the body or 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 |
|---|---|---|
| On-Body Delivery System (OBDS)/Multiple Bolus InjectorUsed to administer placebo SC. | Device | On-Body Delivery System (OBDS)/Multiple Bolus Injector |
| Single Auto InjectorUsed to administer placebo SC. | Device | Single Auto Injector |
| PlaceboAdministered SC. | Drug | On-Body Delivery System (OBDS)/Multiple Bolus Injector, Single Auto Injector |
Primary outcome
Number of Participants with One or More Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Device
Time frame: Baseline through day 7
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
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 1 Mar 2023.
- 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 Phase 1 study testing On-Body Delivery System (OBDS)/Multiple Bolus Injector and Single Auto Injector in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
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 15 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 1 Mar 2023. 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 Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with One or More Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Device (time frame: Baseline through day 7). 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 1 Mar 2023.