Healthy
Conditions
Brief summary
The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.
Interventions
BIOLOGICALLY3074828
Administered SC
DEVICEAuto-injector (AI)
AI to administer LY3074828
DEVICEPrefilled syringe (PFS)
PFS to administer LY3074828
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy participants.
Exclusion criteria
* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females) * Must not show evidence of active or latent tuberculosis (TB) * Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study * Must not have been treated with steroids within 1 month of screening, or intend to during the study * Must not be immunocompromised * Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1 * Must not have significant allergies to humanised monoclonal antibodies * Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions * Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Must not have had breast cancer within the past 10 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device | Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose | Pharmacokinetics: Cmax of LY3074828 |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device | Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose | Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 |
| Visual Analogue Scale (VAS) Pain Assessment by Device | Day 1: 1, 5 (±1.5) and 15 (±2) minutes | The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain. |
| Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Day 1: 1, 5 (±1.5) and 15 (±2) minutes | The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm. | 11 |
| Test 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh. | 11 |
| Test 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen. | 11 |
| Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.The second injection was administered 20 (±2) minutes after the first injection. | 11 |
| Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.The second injection was administered 20 (±2) minutes after the first injection. | 11 |
| Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.The second injection was administered 20 (±2) minutes after the first injection. | 11 |
| Total | 66 |
Baseline characteristics
| Characteristic | Test 1: 250 mg LY3074828 | Total | Reference 3: 250 mg LY3074828 | Reference 2: 250 mg LY3074828 | Reference 1: 250 mg LY3074828 | Test 3: 250 mg LY3074828 | Test 2: 250 mg LY3074828 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 14.3 | 43.6 years STANDARD_DEVIATION 12.6 | 45.0 years STANDARD_DEVIATION 12.9 | 42.8 years STANDARD_DEVIATION 12.3 | 44.1 years STANDARD_DEVIATION 14.7 | 45.4 years STANDARD_DEVIATION 9.4 | 39.9 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 28 Participants | 7 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 38 Participants | 4 Participants | 7 Participants | 7 Participants | 6 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 14 Participants | 0 Participants | 4 Participants | 1 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 48 Participants | 11 Participants | 7 Participants | 10 Participants | 6 Participants | 6 Participants |
| Region of Enrollment United States | 11 Participants | 66 Participants | 11 Participants | 11 Participants | 11 Participants | 11 Participants | 11 Participants |
| Sex: Female, Male Female | 7 Participants | 39 Participants | 7 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 27 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 3 / 11 | 6 / 11 | 2 / 11 | 3 / 11 | 6 / 11 | 4 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device
Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828
Time frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Population: All participants who received at least one dose of study drug. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 250 mg LY3074828 AI | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device | 357 microgram*day per millileter (μg*day/mL) | Geometric Coefficient of Variation 38 |
| 250 mg LY3074828 PFS | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device | 340 microgram*day per millileter (μg*day/mL) | Geometric Coefficient of Variation 38 |
Primary
Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device
Pharmacokinetics: Cmax of LY3074828
Time frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Population: All participants who received at least one dose of study drug. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 250 mg LY3074828 AI | Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device | 22.2 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 40 |
| 250 mg LY3074828 PFS | Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device | 18.7 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 34 |
Primary
Visual Analogue Scale (VAS) Pain Assessment by Device
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device | 1 min | 25.2 millimeter | Standard Deviation 20 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device | 15 min (±2) | 1.9 millimeter | Standard Deviation 3.1 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device | 5 min (±1.5) | 12.0 millimeter | Standard Deviation 15.8 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device | 5 min (±1.5) | 6.1 millimeter | Standard Deviation 7 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device | 15 min (±2) | 2.4 millimeter | Standard Deviation 2.8 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device | 1 min | 22.6 millimeter | Standard Deviation 18.3 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device | 1 min | 18.3 millimeter | Standard Deviation 15.1 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device | 15 min (±2) | 2.2 millimeter | Standard Deviation 4.3 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device | 5 min (±1.5) | 6.0 millimeter | Standard Deviation 6.7 |
Primary
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh: 1 min | 26.8 millimeter | Standard Deviation 15.5 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 15 min (±2) | 2.2 millimeter | Standard Deviation 2.1 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh:15 min (±2) | 0.9 millimeter | Standard Deviation 1.3 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh: 5 min (±1.5) | 13.1 millimeter | Standard Deviation 12.3 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 1 min | 25.9 millimeter | Standard Deviation 17.2 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 5 min (±1.5) | 17.4 millimeter | Standard Deviation 23.3 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 15 min (±2) | 2.6 millimeter | Standard Deviation 4.8 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 5 min (±1.5) | 5.6 millimeter | Standard Deviation 5.4 |
| 250 mg LY3074828 AI | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 1 min | 22.9 millimeter | Standard Deviation 27.2 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh: 5 min (±1.5) | 6.2 millimeter | Standard Deviation 6.6 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 1 min | 19.0 millimeter | Standard Deviation 12 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 5 min (±1.5) | 4.5 millimeter | Standard Deviation 5.5 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 15 min (±2) | 1.8 millimeter | Standard Deviation 2.4 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh: 1 min | 19.6 millimeter | Standard Deviation 20.9 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh:15 min (±2) | 3.0 millimeter | Standard Deviation 3.6 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 1 min | 29.2 millimeter | Standard Deviation 20.6 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 5 min (±1.5) | 7.5 millimeter | Standard Deviation 8.8 |
| 250 mg LY3074828 PFS | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 15 min (±2) | 2.4 millimeter | Standard Deviation 2.4 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 15 min (±2) | 2.0 millimeter | Standard Deviation 2.9 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 1 min | 15.6 millimeter | Standard Deviation 12.3 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 1 min | 18.7 millimeter | Standard Deviation 13.4 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Arm: 5 min (±1.5) | 5.0 millimeter | Standard Deviation 6 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 15 min (±2) | 1.2 millimeter | Standard Deviation 1.9 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh: 5 min (±1.5) | 7.9 millimeter | Standard Deviation 7.8 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh: 1 min | 20.5 millimeter | Standard Deviation 19.6 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Abdomen: 5 min (±1.5) | 5.0 millimeter | Standard Deviation 6.4 |
| 250 mg LY3074828 PFS Second Injection | Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location | Thigh:15 min (±2) | 3.5 millimeter | Standard Deviation 6.7 |