Healthy
Conditions
Brief summary
The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.
Interventions
DRUGLY3074828
Administered subcutaneously (SC)
DEVICEPre-filled syringe (PFS)
PFS used to administer LY3074828
DEVICEAutoinjector (AI)
AI used 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
\- Must be healthy males or females
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 (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 | PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828 | Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85 | PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3074828 |
| Visual Analog Scale (VAS) Pain Score by Device | Day 1: 1, 5 (±1.5) and 15 (±2) minutes | The pain VAS 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 (severe pain). |
| Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | Day 1: 1, 5 (±1.5) and 15 (±2) minutes | The pain VAS 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 (severe pain). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test 1: 125 mg LY3074828 Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL Autoinjector (AI) administered in the arm. | 11 |
| Test 2: 125 mg LY3074828 Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh. | 11 |
| Test 3: 125 mg LY3074828 Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen. | 11 |
| Reference 1: 125 mg LY3074828 Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm. | 11 |
| Reference 2: 125 mg LY3074828 Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh. | 11 |
| Reference 3: 125 mg LY3074828 Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen. | 11 |
| Total | 66 |
Baseline characteristics
| Characteristic | Test 1: 125 mg LY3074828 | Total | Reference 3: 125 mg LY3074828 | Reference 2: 125 mg LY3074828 | Reference 1: 125 mg LY3074828 | Test 3: 125 mg LY3074828 | Test 2: 125 mg LY3074828 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 12.9 | 40.7 years STANDARD_DEVIATION 12.3 | 43.5 years STANDARD_DEVIATION 10.8 | 41.3 years STANDARD_DEVIATION 11.8 | 37.3 years STANDARD_DEVIATION 15.2 | 44.8 years STANDARD_DEVIATION 11.7 | 35.8 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 21 Participants | 3 Participants | 3 Participants | 4 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 45 Participants | 8 Participants | 8 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 | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 14 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 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 | 6 Participants | 48 Participants | 8 Participants | 8 Participants | 7 Participants | 10 Participants | 9 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 | 36 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 30 Participants | 5 Participants | 5 Participants | 6 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 | 2 / 11 | 2 / 11 | 1 / 11 | 2 / 11 | 7 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
Time frame: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
Population: All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate solution formulation using a 1-mL PFS and a 1-mL AI.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 125 mg LY3074828 AI | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 9.19 microgram/milliliter (ug/mL) | Geometric Coefficient of Variation 44 |
| 125 mg LY3074828 PFS | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 8.19 microgram/milliliter (ug/mL) | Geometric Coefficient of Variation 56 |
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3074828
Time frame: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
Population: All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate formulation using a 1-mL PFS and a 1-mL AI.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 125 mg LY3074828 AI | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828 | 149 ug*day/mL | Geometric Coefficient of Variation 38 |
| 125 mg LY3074828 PFS | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828 | 133 ug*day/mL | Geometric Coefficient of Variation 50 |
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration
Time frame: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
Population: All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate solution formulation using a 1-mL PFS and a 1-mL AI.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 125 mg LY3074828 AI | PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration | 146 microgram*day/milliliter (ug*day/mL) | Geometric Coefficient of Variation 39 |
| 125 mg LY3074828 PFS | PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration | 130 microgram*day/milliliter (ug*day/mL) | Geometric Coefficient of Variation 51 |
Primary
Visual Analog Scale (VAS) Pain Score by Device
The pain VAS 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 (severe 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 |
|---|---|---|---|---|
| 125 mg LY3074828 AI | Visual Analog Scale (VAS) Pain Score by Device | 1 Minute | 27.2 millimeter (mm) | Standard Deviation 25 |
| 125 mg LY3074828 AI | Visual Analog Scale (VAS) Pain Score by Device | 5 Minutes (±1.5) | 8.3 millimeter (mm) | Standard Deviation 14.3 |
| 125 mg LY3074828 AI | Visual Analog Scale (VAS) Pain Score by Device | 15 Minute (±2) | 2.3 millimeter (mm) | Standard Deviation 5.8 |
| 125 mg LY3074828 PFS | Visual Analog Scale (VAS) Pain Score by Device | 1 Minute | 22.9 millimeter (mm) | Standard Deviation 21.5 |
| 125 mg LY3074828 PFS | Visual Analog Scale (VAS) Pain Score by Device | 5 Minutes (±1.5) | 10.9 millimeter (mm) | Standard Deviation 15.5 |
| 125 mg LY3074828 PFS | Visual Analog Scale (VAS) Pain Score by Device | 15 Minute (±2) | 2.8 millimeter (mm) | Standard Deviation 6.3 |
Primary
Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location
The pain VAS 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 (severe 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 |
|---|---|---|---|---|
| 125 mg LY3074828 AI | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 5 Minutes (±1.5) | 6.5 millimeter (mm) | Standard Deviation 9.8 |
| 125 mg LY3074828 AI | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 1 Minute | 30.1 millimeter (mm) | Standard Deviation 24.9 |
| 125 mg LY3074828 AI | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 15 Minutes (±2) | 1.8 millimeter (mm) | Standard Deviation 2.9 |
| 125 mg LY3074828 PFS | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 5 Minutes (±1.5) | 12.2 millimeter (mm) | Standard Deviation 22 |
| 125 mg LY3074828 PFS | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 1 Minute | 27.4 millimeter (mm) | Standard Deviation 30.5 |
| 125 mg LY3074828 PFS | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 15 Minutes (±2) | 3.8 millimeter (mm) | Standard Deviation 9.5 |
| Test 3: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 5 Minutes (±1.5) | 6.4 millimeter (mm) | Standard Deviation 7.1 |
| Test 3: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 1 Minute | 24.1 millimeter (mm) | Standard Deviation 20.9 |
| Test 3: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 15 Minutes (±2) | 1.4 millimeter (mm) | Standard Deviation 2.5 |
| Reference 1: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 5 Minutes (±1.5) | 11.8 millimeter (mm) | Standard Deviation 20.1 |
| Reference 1: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 1 Minute | 26.7 millimeter (mm) | Standard Deviation 23.5 |
| Reference 1: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 15 Minutes (±2) | 3.6 millimeter (mm) | Standard Deviation 10.1 |
| Reference 2: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 5 Minutes (±1.5) | 8.9 millimeter (mm) | Standard Deviation 13.7 |
| Reference 2: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 1 Minute | 22.5 millimeter (mm) | Standard Deviation 25.6 |
| Reference 2: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 15 Minutes (±2) | 1.7 millimeter (mm) | Standard Deviation 2 |
| Reference 3: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 1 Minute | 19.5 millimeter (mm) | Standard Deviation 15.5 |
| Reference 3: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 15 Minutes (±2) | 3.1 millimeter (mm) | Standard Deviation 4.4 |
| Reference 3: 125 mg LY3074828 | Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location | 5 Minutes (±1.5) | 11.9 millimeter (mm) | Standard Deviation 13.2 |