Healthy Adult Subjects
Conditions
Brief summary
The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.
Interventions
BIOLOGICALPegilodecakin
Administered SQ
Sponsors
Eli Lilly and Company
ARMO BioSciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening * Must be Human Immunodeficiency Virus (HIV) negative by HIV 1/0/2 testing. * Must be Hepatitis B (HBV) surface antigen negative * Must be Hepatitis C (HCV) antibody negative * Females must have a negative serum pregnancy test
Exclusion criteria
* Pregnant or lactating subjects * Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing * Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance * Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing * Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) * Have been vaccinated within 90 days of study dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin | Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose) | Pharmacokinetic (PK): maximum drug concentration (Cmax) of Pegilodecakin. |
| PK: Time of Maximum Concentration (Tmax) of Pegilodecakin | Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose) | Time of maximum serum concentration (Tmax) of Pegilodecakin. |
| PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC[0-inf] of Pegilodecakin | Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose) | PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC\[0-inf\] of Pegilodecakin. |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Participant flow
Pre-assignment details
2-way crossover study with 7 days washout period between doses.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 9.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 10 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
None listed