Healthy
Conditions
Brief summary
The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions \[ISRs\]) will be collected.
Interventions
BIOLOGICALIxekizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male participants or female participants who agree not to get pregnant * Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study
Exclusion criteria
* Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study * Are allergic or hypersensitive to the study medicine * Have dullness or loss of sensitivity on either side of your abdomen * Have any condition that could affect pain perception from an injection * Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study * Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection * Show evidence of active or latent tuberculosis (TB) * Presence of significant neuropsychiatric disorder or a recent history of depression * Have excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments * Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant if participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injection Pain Visual Analog Scale (VAS) Score | Day 1, 8, and 15: Immediately (within 1 minute) after injection | The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (\>30 and ≤70), and severe pain (\>70). 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 imaginable pain). |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized to a treatment sequence in one of three periods. The study was stopped for some participants per sponsor decision and these participants did not move on to subsequent periods in the study at the protocol interim analysis.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All randomized participants who received at least one 80 milligram (mg) dose of ixekizumab administered as an SC injection in a prefilled syringe in one of three periods. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 2 (Day 8) | Adverse Event | 1 | 2 | 2 |
| Period 2 (Day 8) | Physician Decision | 0 | 1 | 0 |
| Period 2 (Day 8) | Sponsor Decision | 8 | 6 | 5 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 44.5 Years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 70 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 63 | 0 / 61 |
| other Total, other adverse events | 3 / 61 | 5 / 63 | 6 / 61 |
| serious Total, serious adverse events | 0 / 61 | 0 / 63 | 0 / 61 |
Outcome results
Primary
Injection Pain Visual Analog Scale (VAS) Score
The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (\>30 and ≤70), and severe pain (\>70). 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 imaginable pain).
Time frame: Day 1, 8, and 15: Immediately (within 1 minute) after injection
Population: All randomized participants who received at least one dose of study drug in a treatment sequence.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab (Reference) | Injection Pain Visual Analog Scale (VAS) Score | 25.3 millimeter (mm) | Standard Deviation 24.7 |
| Ixekizumab (Test 1) | Injection Pain Visual Analog Scale (VAS) Score | 3.3 millimeter (mm) | Standard Deviation 7 |
| Ixekizumab (Test 2) | Injection Pain Visual Analog Scale (VAS) Score | 4.1 millimeter (mm) | Standard Deviation 8.2 |
p-value: <0.000195% CI: [-26.9, -16.48]Mixed Models Analysis
p-value: <0.000195% CI: [-26.39, -15.88]Mixed Models Analysis
p-value: 0.834195% CI: [-4.65, 5.75]Mixed Models Analysis