Healthy
Conditions
Brief summary
The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is when given by injection into a vein or just under the skin to healthy participants. Blood tests will be done to check how much LY3478006 is in the bloodstream and how long the body takes to get rid of it. For each participant, the study will last up to about 16 weeks, including screening.
Interventions
DRUGLY3478006 - IV
Administered IV
DRUGLY3478006 - SC
Administered SC
DRUGPlacebo - IV
Administered IV
DRUGPlacebo - SC
Administered SC
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
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination * Women not of childbearing potential * Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at screening
Exclusion criteria
* Have clinically significant abnormal electrocardiogram (ECG) results * Have persistent abnormal blood pressure or pulse rate, as determined by the investigator * Have evidence of orthostatic hypotension, defined as a decrease in systolic or diastolic blood pressure greater than or equal to (≥)20 millimeters of mercury (mmHg) or ≥10 mmHg, respectively * Have significant history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders * Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy * Have significant allergies to humanized monoclonal antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through study completion (up to 109 days) | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006 | Predose; Day 1 with end of infusion, 3, 6, 12 hours | Cmax of LY3478006 was evaluated. |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006 | Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85 | AUC0-∞ of LY3478006 was evaluated. The unit of measure is hour\*microgram per milliliter (hr\*mcg/mL). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 10 mg LY3478006 - IV Participants received single dose of 10 mg LY3478006 administered IV. | 3 |
| Placebo - IV Participants received single dose of placebo administered IV. | 1 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | 10 mg LY3478006 - IV | Total | Placebo - IV |
|---|---|---|---|
| Age, Continuous | 34.7 years STANDARD_DEVIATION 10.4 | 34.3 years STANDARD_DEVIATION 8.5 | 33 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 3 / 3 | 0 / 1 |
| serious Total, serious adverse events | 3 / 3 | 0 / 1 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Time frame: Baseline through study completion (up to 109 days)
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10 mg LY3478006 - IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 3 Participants |
| Placebo - IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006
Cmax of LY3478006 was evaluated.
Time frame: Predose; Day 1 with end of infusion, 3, 6, 12 hours
Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg LY3478006 - IV | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006 | 2.3 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 22 |
Secondary
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006
AUC0-∞ of LY3478006 was evaluated. The unit of measure is hour\*microgram per milliliter (hr\*mcg/mL).
Time frame: Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85
Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg LY3478006 - IV | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006 | 550 hr*mcg/mL | Geometric Coefficient of Variation 8.03 |