Healthy ParticipantsPhase 1NCT05154968
A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants
A Phase 1 study testing Sodium chloride, Citrate buffer and Mannitol in people with Healthy Participants, run by Eli Lilly and Company at 1 site in Canada.
Trial summary
The main purpose of the study is to assess the injection site pain intensity of two formulations using prefilled autoinjector device in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Sodium chloride, Citrate buffer and Mannitol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2021to 14 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoker
- BMI greater than (>)18.5 and less than (<) 30.0 kilograms per square meter (kg/m2)
- Body weight greater than or equal to (≥) 50.0 kg for males and ≥45.0 kg for females
- Are in good health, as determined by the investigator (or designee) to have no clinically significant findings from medical and surgical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations
- Are reliable and willing to make themselves available for the duration of the study, are willing to follow study procedures, and demonstrate the ability to self-inject
Who cannot join
- Are pregnant or breastfeeding
- Have a positive urine drug screen or alcohol breath test at screening Have participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing or concomitant participation in an investigational study involving no drug or device administration
- Have known allergic reactions to any components of mannitol or the placebo matrix or related compounds or history of significant atopy
- Have self-perceived dullness or loss of sensation on either side of the body or the abdomen
- Have tattoos or scars over the abdomen or other factors (e.g., rash, excessive folds of skin) that, in the Investigator's opinion, would interfere with injection site assessments
- Are currently using painkillers, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs). Intend to use prescription or over-the-counter medication for pain or inflammation within 7 days prior to the first injection
- Have any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Injection-Site Pain of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Subjects
The main purpose of the study is to assess the injection site pain intensity of two formulations using prefilled autoinjector device in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Sodium chloride, Citrate buffer, Mannitol, Prefilled Autoinjector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chlorideDrug
Administered SC infusion.
Citrate bufferDrug
Administered SC infusion.
MannitolDrug
Administered SC infusion.
Prefilled AutoinjectorDevice
Used to administer the drug through SC infusion.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (ABCD) | Experimental | Participants will receive 1 millilitre (ml) subcutaneous (SC) injection of treatment A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at the potential of hydrogen (pH) 5.7) followed by treatments B (higher pain Room Temperature [RT] solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), C (lower pain refrigerated solution contains mannitol), and D (lower pain RT solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. Receives: Drug: Sodium chloride; Drug: Citrate buffer; Drug: Mannitol; Device: Prefilled Autoinjector |
| Sequence 2 (BDAC) | Experimental | Participants will receive 1 ml SC injection of treatment B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) followed by treatments D (lower pain RT solution contains mannitol), A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), and C (lower pain refrigerated solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. Receives: Drug: Sodium chloride; Drug: Citrate buffer; Drug: Mannitol; Device: Prefilled Autoinjector |
| Sequence 3 (CADB) | Experimental | Participants will receive 1 ml SC injection of treatment C (lower pain refrigerated solution contains mannitol) followed by treatments A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), D (lower pain RT solution contains mannitol), and B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. Receives: Drug: Sodium chloride; Drug: Citrate buffer; Drug: Mannitol; Device: Prefilled Autoinjector |
| Sequence 4 (DCBA) | Experimental | Participants will receive 1 ml SC injection of treatment D (lower pain RT solution contains mannitol) followed by treatments C (lower pain refrigerated solution contains mannitol), B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), and A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. Receives: Drug: Sodium chloride; Drug: Citrate buffer; Drug: Mannitol; Device: Prefilled Autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) Pain score at Injection Site at Time Zero (T0)
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst possible pain).
Measured: within 1 minute post injection
Secondary outcomes (2)
Visual analogue scale (VAS) Pain score at Injection Site after Time Zero (T0)
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst possible pain).
Measured: within 5, 10, 15, 30 and 60 minutes post injection
Number of Participants with Injection Site Reactions (ISR)
ISR will consists of rating the severity of skin reaction at the injection site using the scores below 0=no reaction, 1= easily tolerated erythema and/or light bruising, 2= distributing erythema with swelling and/or distributing bruising, 3=almost intolerable symptoms, or clinically definite skin necrosis, characterized by any of the following: oozing, weeping, skin breakdown, ulceration, scar formation. Higher the score worst the injection site reaction.
Measured: 10 and 60 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start24 Nov 2021
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154968
- Sponsor's protocol ID
- 18167
- Other IDs
- J3G-MC-S003
- Status last verified
- Jan 2022
- First submitted
- 19 Nov 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Injection-Site Pain of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05154968
- Acronym / sponsor ID
- 18167
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 13 Dec 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 the study is to assess the injection site pain intensity of two formulations using prefilled autoinjector device in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (ABCD) | Experimental | Drug: Sodium chloride, Drug: Citrate buffer, Drug: Mannitol, Device: Prefilled AutoinjectorParticipants will receive 1 millilitre (ml) subcutaneous (SC) injection of treatment A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at the potential of hydrogen (pH) 5.7) followed by treatments B (higher pain Room Temperature [RT] solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), C (lower pain refrigerated solution contains mannitol), and D (lower pain RT solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
| Sequence 2 (BDAC) | Experimental | Drug: Sodium chloride, Drug: Citrate buffer, Drug: Mannitol, Device: Prefilled AutoinjectorParticipants will receive 1 ml SC injection of treatment B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) followed by treatments D (lower pain RT solution contains mannitol), A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), and C (lower pain refrigerated solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
| Sequence 3 (CADB) | Experimental | Drug: Sodium chloride, Drug: Citrate buffer, Drug: Mannitol, Device: Prefilled AutoinjectorParticipants will receive 1 ml SC injection of treatment C (lower pain refrigerated solution contains mannitol) followed by treatments A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), D (lower pain RT solution contains mannitol), and B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
| Sequence 4 (DCBA) | Experimental | Drug: Sodium chloride, Drug: Citrate buffer, Drug: Mannitol, Device: Prefilled AutoinjectorParticipants will receive 1 ml SC injection of treatment D (lower pain RT solution contains mannitol) followed by treatments C (lower pain refrigerated solution contains mannitol), B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), and A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-smoker
- BMI greater than (>)18.5 and less than (<) 30.0 kilograms per square meter (kg/m2)
- Body weight greater than or equal to (≥) 50.0 kg for males and ≥45.0 kg for females
- Are in good health, as determined by the investigator (or designee) to have no clinically significant findings from medical and surgical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations
- Are reliable and willing to make themselves available for the duration of the study, are willing to follow study procedures, and demonstrate the ability to self-inject
Key exclusion criteria (7 listed)
- Are pregnant or breastfeeding
- Have a positive urine drug screen or alcohol breath test at screening Have participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing or concomitant participation in an investigational study involving no drug or device administration
- Have known allergic reactions to any components of mannitol or the placebo matrix or related compounds or history of significant atopy
- Have self-perceived dullness or loss of sensation on either side of the body or the abdomen
- Have tattoos or scars over the abdomen or other factors (e.g., rash, excessive folds of skin) that, in the Investigator's opinion, would interfere with injection site assessments
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 |
|---|---|---|
| Sodium chlorideAdministered SC infusion. | Drug | Sequence 1 (ABCD), Sequence 2 (BDAC), Sequence 3 (CADB), Sequence 4 (DCBA) |
| Citrate bufferAdministered SC infusion. | Drug | Sequence 1 (ABCD), Sequence 2 (BDAC), Sequence 3 (CADB), Sequence 4 (DCBA) |
| MannitolAdministered SC infusion. | Drug | Sequence 1 (ABCD), Sequence 2 (BDAC), Sequence 3 (CADB), Sequence 4 (DCBA) |
| Prefilled AutoinjectorUsed to administer the drug through SC infusion. | Device | Sequence 1 (ABCD), Sequence 2 (BDAC), Sequence 3 (CADB), Sequence 4 (DCBA) |
Primary outcome
Visual analogue scale (VAS) Pain score at Injection Site at Time Zero (T0)
Time frame: within 1 minute post injection
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst possible pain).
2 secondary outcomes
Visual analogue scale (VAS) Pain score at Injection Site after Time Zero (T0)
Time frame: within 5, 10, 15, 30 and 60 minutes post injection
Number of Participants with Injection Site Reactions (ISR)
Time frame: 10 and 60 minutes post injection
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 13 Jan 2022.
- 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.
Study Director 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 Sodium chloride, Citrate buffer and Mannitol in people with Healthy Participants, run by Eli Lilly and Company at 1 site in Canada.
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 5 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 13 Jan 2022. 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 Canada. 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?
Visual analogue scale (VAS) Pain score at Injection Site at Time Zero (T0) (time frame: within 1 minute post injection). 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 13 Jan 2022.