Healthy Adult Subjects
Conditions
Brief summary
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
Detailed description
This is an open-label, randomized, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.
Interventions
BIOLOGICALPegilodecakin
Administered SQ
Sponsors
Eli Lilly and Company
ARMO BioSciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female between 18 and 55 years of age, inclusive 2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening 3. Must be HIV negative by HIV 1/0/2 testing 4. Must be Hepatitis B (HBV) surface antigen negative 5. Must be Hepatitis C (HCV) antibody negative 6. Females must have a negative serum pregnancy test 7. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug
Exclusion criteria
1. Pregnant or lactating subjects 2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing 3. Have poor venous access and are unable to donate blood 4. Have been vaccinated within 90 days of study dosing 5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance 6. Have history of significant drug sensitivity or drug allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK): Maximal Serum Concentration (Cmax) of Pegilodecakin After a Single Dose (Day 1) | Predose, 1, 2, 4, 8, 12, 16, 24, 36, 48, 60 and 72 hours (hrs) postdose | Pharmacokinetic (PK): Maximal serum concentration (Cmax) of pegilodecakin after a single dose (Day 1). |
| PK: Time of Maximum Concentration (Tmax) of Pegilodecakin After a Single Dose (Day 1) | Predose, 1, 2, 4, 8, 12, 16, 24, 36, 48, 60 and 72 hrs postdose | PK: Time of maximum serum concentration (Tmax) of pegilodecakin after a single dose (Day 1). |
| PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC[0-inf] of Pegilodecakin After a Single Dose (Day 1) | Predose, 1, 2, 4, 8, 12, 16, 24, 36, 48, 60 and 72 hrs postdose | PK: Area under the serum concentration versus time curve from time zero to infinity AUC\[0-inf\] of pegilodecakin after a single dose (Day 1). |
| PK: Apparent Total Body Clearance (CL/F) of Pegilodecakin After a Single Dose (Day 1) | Predose, 1, 2, 4, 8, 12, 16, 24, 36, 48, 60 and 72 hrs postdose | PK: Apparent total body clearance (CL/F) of pegilodecakin after a single dose (Day 1). |
| PK: Maximum Serum Concentration at Steady State (Cmax,ss) of Pegilodecakin After Multiple Dose (Day 4 to 9) | Day 4 (Predose, 2, 4, 8, 12 and 24 hours postdose), Day 6 (Predose, 4 and 8 hours), Day 7 (Predose), Day 8 (Predose), Day 9 (Predose, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postdose) | Maximum serum concentration of pegilodecakin at steady state (Cmax,ss). Cmax,ss takes all time points into account and one value is reported. |
| PK: Time of Maximum Serum Concentration at Steady State (Tmax,ss) of Pegilodecakin After Multiple Dose (Day 4 to 9) | Day 4 (Predose, 2, 4, 8, 12 and 24 hours postdose), Day 6 (Predose, 4 and 8 hours), Day 7 (Predose), Day 8 (Predose), Day 9 (Predose, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postdose) | Time of maximum serum concentration (Tmax,ss) of pegilodecakin at steady state. Tmaxss takes all time points into account and one value is reported. |
| PK: Area Under the Serum Concentration Versus Time Curve at Steady State (AUC[0-tlast], ss) of Pegilodecakin After Multiple Dose (Day 4 to 9) | Day 4 (Predose, 2, 4, 8, 12 and 24 hours postdose), Day 6 (Predose, 4 and 8 hours), Day 7 (Predose), Day 8 (Predose), Day 9 (Predose, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postdose) | Area under the serum concentration versus time curve of pegilodecakin at steady state from time zero to tlast (AUC\[0-tlast\], ss). AUC takes all time points into account and one value is reported. |
| PK: Apparent Total Body Clearance at Steady State (CLss/F) of Pegilodecakin After Multiple Dose (Day 4 to 9) | Day 4 (Predose, 2, 4, 8, 12 and 24 hours postdose), Day 6 (Predose, 4 and 8 hours), Day 7 (Predose), Day 8 (Predose), Day 9 (Predose, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postdose) | Apparent total body clearance of pegilodecakin at steady state (CLss/F). CLss/F takes all time points into account and one value is reported. |
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 35.5 Years STANDARD_DEVIATION 10.28 |
| Body Mass Index (BMI) | 27.25 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 1.833 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 6 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 | 11 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
None listed