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 2026-07-07.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Participants received AM0010 (pegilodecakin) subcutaneous (SQ) doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 1.6 mg at 4 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Biological: Pegilodecakin
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 4 mg/mL administered as 0.1 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections for body weight \>80 kg.
Biological: Pegilodecakin
Participants received AM0010 (pegilodecakin) SQ doses of 0.4 mg at 2 mg/mL administered as 0.2 mL injections for body weight ≤80 kg and SQ doses of 0.8 mg at 2 mg/mL administered as 0.4 mL injections for body weight \>80 kg.
Biological: Pegilodecakin
Pegilodecakin alone administered SQ
Also known as: LY3500518, AM0010
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
Maximal serum concentration (Cmax) of pegilodecakin is reported.
Time frame: 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]
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin
Time of maximum serum concentration (Tmax) of Pegilodecakin is reported.
Time frame: 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]
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
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.
Time frame: 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]
PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin
Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period.
Time frame: 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]
| Milestone | Sequence ABC | Sequence BAC | Sequence CBA |
|---|---|---|---|
| Started | 4 | 4 | 4 |
| Received at least 1 dose of study drug | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence ABC | Sequence BAC | Sequence CBA |
|---|---|---|---|
| Started | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence ABC | Sequence BAC | Sequence CBA |
|---|---|---|---|
| Started | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 |
Maximal serum concentration (Cmax) of pegilodecakin is reported.
| picogram per milliliter (pg/mL) | Pegilodecakin: Treatment A | Pegilodecakin: Treatment B | Pegilodecakin: Treatment C |
|---|---|---|---|
| Body Weight ≤80 kg | 8590 ± 51 | 3820 ± 54 | 4130 ± 81 |
| Body Weight >80 kg | 18500 ± 97 | 5970 ± 70 | 11200 ± 25 |
Time of maximum serum concentration (Tmax) of Pegilodecakin is reported.
| hours (h) | Pegilodecakin: Treatment A | Pegilodecakin: Treatment B | Pegilodecakin: Treatment C |
|---|---|---|---|
| Body Weight ≤80 kg | 16.00 (8.00 to 24.00) | 8.00 (4.00 to 12.00) | 12.00 (8.00 to 16.00) |
| Body Weight >80 kg | 12.00 (12.00 to 12.02) | 12.00 (8.00 to 24.00) | 12.00 (12.00 to 12.00) |
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.
| hour*picogram per milliliter (h*pg/mL) | Pegilodecakin: Treatment A | Pegilodecakin: Treatment B | Pegilodecakin: Treatment C |
|---|---|---|---|
| Body Weight ≤80 kg: AUC(0-tlast) | 334000 ± 54 | 119000 ± 67 | 149000 ± 90 |
| Body Weight >80 kg: AUC(0-tlast) | 593000 ± 73 | 187000 ± 51 | 342000 ± 24 |
| Body Weight ≤80 kg: AUC(0-72) | 306000 ± 51 | 117000 ± 63 | 139000 ± 83 |
| Body Weight >80 kg: AUC(0-72) | 514000 ± 81 | 176000 ± 43 | 298000 ± 28 |
| Body Weight ≤80 kg: AUC(0-inf) | 362000 ± 51 | 134000 ± 65 | 162000 ± 86 |
| Body Weight >80 kg: AUC(0-inf) | 606000 ± 70 | 259000 ± 13 | 349000 ± 23 |
Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period.
| Liter/hour (L/h) | Pegilodecakin: Treatment A | Pegilodecakin: Treatment B | Pegilodecakin: Treatment C |
|---|---|---|---|
| Body Weight ≤80 kg | 2.21 ± 51 | 2.98 ± 65 | 2.47 ± 86 |
| Body Weight >80 kg | 2.64 ± 70 | 3.08 ± 13 | 2.29 ± 23 |
Collected over Up To 22 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegilodecakin: Treatment A | 0/12 (0%) | 0/12 (0%) | 10/12 (83.3%) |
| Pegilodecakin: Treatment B | 0/12 (0%) | 0/12 (0%) | 10/12 (83.3%) |
| Pegilodecakin: Treatment C | 0/12 (0%) | 0/12 (0%) | 11/12 (91.7%) |
| Event | Pegilodecakin: Treatment A | Pegilodecakin: Treatment B | Pegilodecakin: Treatment C |
|---|---|---|---|
| Injection site reaction left upper quadrant erythemaGeneral disorders | 1/12 | 0/12 | 7/12 |
| Injection site reaction right upper quadrant erythemaGeneral disorders | 3/12 | 7/12 | 0/12 |
| Injection site reaction right lower quadrant erythemaGeneral disorders | 4/12 | 3/12 | 4/12 |
| Injection site reaction left upper quadrant pruritusGeneral disorders | 1/12 | 0/12 | 3/12 |
| Injection site reaction right lower quadrant pruritusGeneral disorders | 1/12 | 2/12 | 2/12 |
| Injection site reaction right upper quadrant pruritusGeneral disorders | 0/12 | 2/12 | 1/12 |
| Eye irritationEye disorders | 0/12 | 1/12 | 0/12 |
| Abdominal bloatingGastrointestinal disorders | 0/12 | 0/12 | 1/12 |
| Decreased frequency of bowel movementsGastrointestinal disorders | 0/12 | 0/12 | 1/12 |
| NauseaGastrointestinal disorders | 1/12 | 0/12 | 1/12 |
All randomized participants.
| Age, Continuous(years) | Sequence ABC | Sequence BAC | Sequence CBA | Total |
|---|---|---|---|---|
| Mean | 41.0 ± 9.06 | 33.8 ± 7.63 | 28.8 ± 9.57 | 34.5 ± 9.53 |
| Sex: Female, Male(Participants) | Sequence ABC | Sequence BAC | Sequence CBA | Total |
|---|---|---|---|---|
| Female | 1 | 2 | 4 | 7 |
| Male | 3 | 2 | 0 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Sequence ABC | Sequence BAC | Sequence CBA | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 2 | 6 |
| Not Hispanic or Latino | 2 | 2 | 2 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sequence ABC | Sequence BAC | Sequence CBA | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 4 | 3 | 4 | 11 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Sequence ABC | Sequence BAC | Sequence CBA | Total |
|---|---|---|---|---|
| United States | 4 | 4 | 4 | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Feb 2018, 1 month.
Results were first posted in Jul 2026, 8 years 4 months after primary completion.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegilodecakin