Healthy
Conditions
Brief summary
The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.
Interventions
BIOLOGICALIxekizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male participant or female participant who agree to not become pregnant * Are male participant or female participants with chronic stable medical problems, that in the investigator's opinion will not place the subject 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 * 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 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 |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose | Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab |
| PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose | Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days. |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab. | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose | Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized to 1 of 3 treatments, Reference, Test Formulation 1 or Test Formulation 2.
Participants by arm
| Arm | Count |
|---|---|
| Ixekizumab (Reference) Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe. | 33 |
| Ixekizumab (Test 1) Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. | 33 |
| Ixekizumab (Test 2) Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. | 33 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Ixekizumab (Reference) | Total | Ixekizumab (Test 2) | Ixekizumab (Test 1) |
|---|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 13.5 | 44.5 years STANDARD_DEVIATION 15.1 | 49.2 years STANDARD_DEVIATION 15.2 | 41.9 years STANDARD_DEVIATION 15.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 36 Participants | 11 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 63 Participants | 22 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 20 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 77 Participants | 27 Participants | 25 Participants |
| Region of Enrollment United States | 33 Participants | 99 Participants | 33 Participants | 33 Participants |
| Sex: Female, Male Female | 22 Participants | 69 Participants | 24 Participants | 23 Participants |
| Sex: Female, Male Male | 11 Participants | 30 Participants | 9 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 | 1 / 33 |
| other Total, other adverse events | 4 / 33 | 2 / 33 | 5 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 1 / 33 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab
Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab
Time frame: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab (Reference) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | 6.31 microgram/milliliter (ug/mL) | Geometric Coefficient of Variation 48 |
| Ixekizumab (Test 1) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | 6.29 microgram/milliliter (ug/mL) | Geometric Coefficient of Variation 33 |
| Ixekizumab (Test 2) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | 6.50 microgram/milliliter (ug/mL) | Geometric Coefficient of Variation 33 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab
Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC\[0-tlast\]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days.
Time frame: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab (Reference) | PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | 146 microgram*day/milliliter (ug*day/mL) | Geometric Coefficient of Variation 43 |
| Ixekizumab (Test 1) | PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | 153 microgram*day/milliliter (ug*day/mL) | Geometric Coefficient of Variation 37 |
| Ixekizumab (Test 2) | PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | 163 microgram*day/milliliter (ug*day/mL) | Geometric Coefficient of Variation 33 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab.
Area under the plasma concentration versus time curve from zero to infinity (AUC\[0-∞\]) of a single dose of Ixekizumab.
Time frame: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab (Reference) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab. | 152 ug*day/mL | Geometric Coefficient of Variation 45 |
| Ixekizumab (Test 1) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab. | 159 ug*day/mL | Geometric Coefficient of Variation 38 |
| Ixekizumab (Test 2) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab. | 170 ug*day/mL | Geometric Coefficient of Variation 34 |