Healthy Participants
Conditions
Brief 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.
Interventions
DRUGSodium chloride
Administered SC infusion.
DRUGCitrate buffer
Administered SC infusion.
DRUGMannitol
Administered SC infusion.
DEVICEPrefilled Autoinjector
Used to administer the drug through SC infusion.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Partially blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) Pain score at Injection Site at Time Zero (T0) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) Pain score at Injection Site after Time Zero (T0) | within 5, 10, 15, 30 and 60 minutes 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). |
| Number of Participants with Injection Site Reactions (ISR) | 10 and 60 minutes post injection | 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. |
Countries
Canada
Outcome results
None listed