A Phase 1 interventional study of Pegilodecakin in Healthy Adult Subjects, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
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.
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 microgram per kilogram (μg/kg) of pegilodecakin was administered as subcutaneous injection. Flat dosing was used with 2 weight-banded dose levels based on body weight (ie, either 400 μg for participants who weighed 80 kg or less and 800 μg for participants who weighed greater than 80 kg).
Biological: Pegilodecakin
10 μg/kg of pegilodecakin was administered as subcutaneous injection. Flat dosing was used with 2 weight-banded dose levels based on body weight (ie, either 800 μg for participants who weighed 80 kg or less and 1600 μg for participants who weighed greater than 80 kg).
Biological: Pegilodecakin
Administered SQ
Also known as: LY3500518, AM0010
Pharmacokinetic (PK): Maximal Serum Concentration (Cmax) of Pegilodecakin After a Single Dose (Day 1)
Pharmacokinetic (PK): Maximal serum concentration (Cmax) of pegilodecakin after a single dose (Day 1).
Time frame: Predose, 1, 2, 4, 8, 12, 16, 24, 36, 48, 60 and 72 hours (hrs) postdose
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin After a Single Dose (Day 1)
PK: Time of maximum serum concentration (Tmax) of pegilodecakin after a single dose (Day 1).
Time frame: 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: Area under the serum concentration versus time curve from time zero to infinity AUC\[0-inf\] of pegilodecakin after a single dose (Day 1).
Time frame: 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: Apparent total body clearance (CL/F) of pegilodecakin after a single dose (Day 1).
Time frame: Predose, 1, 2, 4, 8, 12, 16, 24, 36, 48, 60 and 72 hrs postdose
PK: Maximum Serum Concentration at Steady State (Cmax,ss) of Pegilodecakin After Multiple Dose (Day 4 to 9)
Maximum serum concentration of pegilodecakin at steady state (Cmax,ss). Cmax,ss takes all time points into account and one value is reported.
Time frame: 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)
PK: Time of Maximum Serum Concentration at Steady State (Tmax,ss) of Pegilodecakin After Multiple Dose (Day 4 to 9)
Time of maximum serum concentration (Tmax,ss) of pegilodecakin at steady state. Tmaxss takes all time points into account and one value is reported.
Time frame: 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)
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)
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.
Time frame: 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)
PK: Apparent Total Body Clearance at Steady State (CLss/F) of Pegilodecakin After Multiple Dose (Day 4 to 9)
Apparent total body clearance of pegilodecakin at steady state (CLss/F). CLss/F takes all time points into account and one value is reported.
Time frame: 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)
| Milestone | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| Started | 12 | 12 |
| Received at least 1 dose of study drug | 12 | 12 |
| Completed | 11 | 11 |
| Not completed | 1 | 1 |
| Withdrew: Adverse event | 1 | 1 |
Pharmacokinetic (PK): Maximal serum concentration (Cmax) of pegilodecakin after a single dose (Day 1).
| picogram per milliliter (pg/mL) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| Pharmacokinetic (PK): Maximal Serum Concentration (Cmax) of Pegilodecakin After a Single Dose (Day 1) | 8311.819 ± 59 | 14975.688 ± 60 |
PK: Time of maximum serum concentration (Tmax) of pegilodecakin after a single dose (Day 1).
| hours | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| PK: Time of Maximum Concentration (Tmax) of Pegilodecakin After a Single Dose (Day 1) | 16.0 (8.13 to 16.0) | 14.0 (8.00 to 24.0) |
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).
| hour*picogram per milliliter (h*pg/mL) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| 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) | 268000 ± 47 | 553000 ± 46 |
PK: Apparent total body clearance (CL/F) of pegilodecakin after a single dose (Day 1).
| Liter/hour (L/h) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| PK: Apparent Total Body Clearance (CL/F) of Pegilodecakin After a Single Dose (Day 1) | 2.24 ± 30 | 1.72 ± 43 |
Maximum serum concentration of pegilodecakin at steady state (Cmax,ss). Cmax,ss takes all time points into account and one value is reported.
| pg/mL | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| PK: Maximum Serum Concentration at Steady State (Cmax,ss) of Pegilodecakin After Multiple Dose (Day 4 to 9) | 12317.757 ± 55 | 19395.650 ± 57 |
Time of maximum serum concentration (Tmax,ss) of pegilodecakin at steady state. Tmaxss takes all time points into account and one value is reported.
| hours | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| PK: Time of Maximum Serum Concentration at Steady State (Tmax,ss) of Pegilodecakin After Multiple Dose (Day 4 to 9) | 12.0 (0 to 12.0) | 8.00 (0 to 12.0) |
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.
| h*pg/mL | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| 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) | 436000 ± 50 | 707000 ± 50 |
Apparent total body clearance of pegilodecakin at steady state (CLss/F). CLss/F takes all time points into account and one value is reported.
| L/h | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| PK: Apparent Total Body Clearance at Steady State (CLss/F) of Pegilodecakin After Multiple Dose (Day 4 to 9) | 2.35 ± 24 | 2.34 ± 43 |
Collected over Baseline Up To 43 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegilodecakin (5 μg/kg) | 0/12 (0%) | 0/12 (0%) | 11/12 (91.7%) |
| Pegilodecakin (10 μg/kg) | 0/12 (0%) | 0/12 (0%) | 11/12 (91.7%) |
| Event | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) |
|---|---|---|
| Injection site erythemaGeneral disorders | 9/12 | 11/12 |
| HeadacheNervous system disorders | 7/12 | 8/12 |
| Injection site pruritusGeneral disorders | 5/12 | 6/12 |
| PyrexiaGeneral disorders | 3/12 | 5/12 |
| MyalgiaMusculoskeletal and connective tissue disorders | 3/12 | 5/12 |
| Injection site lymphadenopathyGeneral disorders | 4/12 | 4/12 |
| NauseaGastrointestinal disorders | 0/12 | 3/12 |
| Injection site painGeneral disorders | 0/12 | 3/12 |
| NasopharyngitisInfections and infestations | 2/12 | 0/12 |
| TinnitusEar and labyrinth disorders | 1/12 | 0/12 |
All randomized participants who received at least one dose of study drug.
| Age, Continuous(Years) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) | Total |
|---|---|---|---|
| Mean | 36.9 ± 10.71 | 34.0 ± 10.08 | 35.5 ± 10.28 |
| Sex: Female, Male(Participants) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 6 | 6 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 10 |
| Not Hispanic or Latino | 7 | 7 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 3 | 2 | 5 |
| White | 8 | 8 | 16 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| Body Mass Index (BMI)(kilograms per square meter (kg/m^2)) | Pegilodecakin (5 μg/kg) | Pegilodecakin (10 μg/kg) | Total |
|---|---|---|---|
| Mean | 27.25 ± 1.833 | 24.96 ± 3.545 | 26.10 ± 2.998 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Oct 2017, 1 month.
Results were first posted in Oct 2026, 8 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegilodecakin