Healthy Volunteers
Conditions
Brief summary
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).
Interventions
DRUGLY3053102
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal blood pressure * Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause * Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m\^2), inclusive, at screening
Exclusion criteria
* Had known allergies to LY3053102 or related compounds * Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication * Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids * Heavy smokers (more than 10 cigarettes a day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | Baseline through Day 31 | A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | Time 0 to 168 hours after study drug administration on Day 1 | AUC curve from time 0 to 168 hours postdose of LY3053102. |
| PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | Time 0 to 168 hours after study drug administration on Day 1 | Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1. |
| Number of Participants Who Developed Anti-LY3053102 Antibodies | Baseline, up to Day 31 | LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a \>=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2 mg LY3053102 LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | 6 |
| 7 mg LY3053102 LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | 6 |
| 20 mg LY3053102 LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | 6 |
| 50 mg LY3053102 LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | 5 |
| 150 mg LY3053102 LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | 6 |
| 405 mg LY3053102 LY3053102: A single dose of 405 mg, administered subcutaneously. | 6 |
| Placebo Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort. | 6 |
| Total | 41 |
Baseline characteristics
| Characteristic | 2 mg LY3053102 | Total | Placebo | 405 mg LY3053102 | 150 mg LY3053102 | 50 mg LY3053102 | 20 mg LY3053102 | 7 mg LY3053102 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 35.2 years STANDARD_DEVIATION 9.7 | 34.8 years STANDARD_DEVIATION 9.4 | 34.5 years STANDARD_DEVIATION 7.4 | 31.0 years STANDARD_DEVIATION 8.9 | 34.3 years STANDARD_DEVIATION 10.7 | 36.2 years STANDARD_DEVIATION 14.7 | 39.7 years STANDARD_DEVIATION 11.1 | 33.2 years STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 41 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 38 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Singapore | 6 participants | 41 participants | 6 participants | 6 participants | 6 participants | 5 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 39 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 6 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 | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 6 / 6 | 4 / 6 | 4 / 5 | 6 / 6 | 5 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Baseline through Day 31
Population: Participants who received at least one dose of LY3053102 or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 mg LY3053102 | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | 5 participants |
| 7 mg LY3053102 | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | 6 participants |
| 20 mg LY3053102 | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | 4 participants |
| 50 mg LY3053102 | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | 4 participants |
| 150 mg LY3053102 | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | 6 participants |
| 405 mg LY3053102 | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | 5 participants |
| Placebo | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs | 6 participants |
Secondary
Number of Participants Who Developed Anti-LY3053102 Antibodies
LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a \>=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.
Time frame: Baseline, up to Day 31
Population: Participants who received at least one dose of LY3053102 or placebo and with evaluable anti-drug (LY3053102) ADA data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 15 | 0 participants |
| 2 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 29 | 0 participants |
| 7 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 15 | 1 participants |
| 7 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 29 | 1 participants |
| 20 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 15 | 0 participants |
| 20 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 29 | 0 participants |
| 50 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 15 | 0 participants |
| 50 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 29 | 0 participants |
| 150 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 15 | 0 participants |
| 150 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 29 | 0 participants |
| 405 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 15 | 0 participants |
| 405 mg LY3053102 | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 29 | 0 participants |
| Placebo | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 15 | 0 participants |
| Placebo | Number of Participants Who Developed Anti-LY3053102 Antibodies | Day 29 | 0 participants |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102
AUC curve from time 0 to 168 hours postdose of LY3053102.
Time frame: Time 0 to 168 hours after study drug administration on Day 1
Population: Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 2 mg LY3053102 | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | 7.24 microgram*hour/milliliter | Geometric Coefficient of Variation 29.6 |
| 7 mg LY3053102 | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | 16.1 microgram*hour/milliliter | Geometric Coefficient of Variation 50.3 |
| 20 mg LY3053102 | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | 94.0 microgram*hour/milliliter | Geometric Coefficient of Variation 45.5 |
| 50 mg LY3053102 | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | 192 microgram*hour/milliliter | Geometric Coefficient of Variation 38 |
| 150 mg LY3053102 | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | 481 microgram*hour/milliliter | Geometric Coefficient of Variation 74 |
| 405 mg LY3053102 | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 | 1810 microgram*hour/milliliter | Geometric Coefficient of Variation 49.1 |
Secondary
PK: Observed Maximum Drug Concentration (Cmax) of LY3053102
Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.
Time frame: Time 0 to 168 hours after study drug administration on Day 1
Population: Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 2 mg LY3053102 | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | 0.0693 microgram/milliliter | Geometric Coefficient of Variation 30.2 |
| 7 mg LY3053102 | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | 0.140 microgram/milliliter | Geometric Coefficient of Variation 52 |
| 20 mg LY3053102 | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | 0.784 microgram/milliliter | Geometric Coefficient of Variation 46.8 |
| 50 mg LY3053102 | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | 1.68 microgram/milliliter | Geometric Coefficient of Variation 44.7 |
| 150 mg LY3053102 | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | 4.49 microgram/milliliter | Geometric Coefficient of Variation 67.6 |
| 405 mg LY3053102 | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 | 16.2 microgram/milliliter | Geometric Coefficient of Variation 49 |