Healthy Adult Subjects
Conditions
Brief summary
To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
Detailed description
An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
Interventions
BIOLOGICALPegilodecakin
Pegilodecakin alone 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
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. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug. 8. 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 |
|---|---|---|
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] | Maximal serum concentration (Cmax) of pegilodecakin is reported. |
| PK: Time of Maximum Concentration (Tmax) of Pegilodecakin | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] | Time of maximum serum concentration (Tmax) of Pegilodecakin is reported. |
| PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] | AUC from time 0 to the time of the last quantifiable concentration \[AUC(0-tlast)\], AUC from time 0 to 72 hours \[AUC(0-72)\] and AUC from time 0 to infinity \[AUC(0-inf)\] of pegilodecakin is reported. |
| PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin | Period 1: Days 1-4 and Day 8 [Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8 predose)]; Period 2: Days 8-11 and Day 15 [same as Days 1-4 and Day 8 (Day 15 predose)]; Period 3: Days 15-18 and Day 22 [same as Days 1-4 and Day 8] | Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period. |
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
3-way crossover study with 7 days washout period between doses.Two dose concentrations and two dose levels per weight bracket (participants who weighed at less than or equal to (≤) 80 kilogram (kg) (Body weight ≤ 80 kg) in the lower bracket and participants who weighed greater than (\>) 80 kg in the higher bracket (Body weight \>80 kg) were evaluated
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 7.63 |
| 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 | 1 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 | 11 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 10 / 12 | 10 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
None listed