Healthy Adult SubjectsPhase 1Willow 2NCT03381547

A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)

A Phase 1 study testing Pegilodecakin in people with Healthy Adult Subjects, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adult Subjects
What is being tested?: Pegilodecakin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2017to 13 Feb 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female between 18 and 55 years of age, inclusive
Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
Must be 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
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.
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

Who cannot join

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
Have poor venous access and are unable to donate blood
Have been vaccinated within 90 days of study dosing
Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
Have history of significant drug sensitivity or drug allergy.

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Development
Austin, Texas, 78744

Other trials in United States

About this study

Official title: An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects

To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.

Read the 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.

Conditions: Healthy Adult Subjects
Being tested: Pegilodecakin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegilodecakinBiological
Also called LY3500518, AM0010
Pegilodecakin alone administered SQ

Study groups in NCT03381547
Study group	Role	What they receive
Pegilodecakin: Treatment A	Experimental	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. Receives: Biological: Pegilodecakin
Pegilodecakin: Treatment B	Experimental	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. Receives: Biological: Pegilodecakin
Pegilodecakin: Treatment C	Experimental	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. Receives: Biological: Pegilodecakin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
Maximal serum concentration (Cmax) of pegilodecakin is reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201713 Feb 2018

First posted22 Dec 2017
Study start18 Dec 2017
Primary completion13 Feb 2018
Study completion13 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03381547
Sponsor's protocol ID: 17298
Other IDs: J1L-AM-JZGF, AM0010-802
Acronym: Willow 2
Status last verified: Jun 2026
First submitted: 18 Dec 2017
Last updated: 7 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Adult Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT03381547
Acronym / sponsor ID: Willow 2 / 17298
Conditions: Healthy Adult Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: ARMO BioSciences
Study start: 18 Dec 2017 (actual)
Primary completion: 13 Feb 2018 (actual)
Study completion: 13 Feb 2018 (actual)
First posted: 22 Dec 2017 (actual)
Results: Posted 7 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pegilodecakin: Treatment A	Experimental	Biological: PegilodecakinParticipants 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.
Pegilodecakin: Treatment B	Experimental	Biological: PegilodecakinParticipants 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.
Pegilodecakin: Treatment C	Experimental	Biological: PegilodecakinParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Male or female between 18 and 55 years of age, inclusive
Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
Must be HIV negative by HIV 1/0/2 testing
Must be Hepatitis B (HBV) surface antigen negative
Must be Hepatitis C (HCV) antibody negative

Key exclusion criteria (6 listed)

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
Have poor venous access and are unable to donate blood
Have been vaccinated within 90 days of study dosing
Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PegilodecakinAlso: LY3500518, AM0010Pegilodecakin alone administered SQ	Biological	Pegilodecakin: Treatment A, Pegilodecakin: Treatment B, Pegilodecakin: Treatment C

Primary outcome

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
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]
Maximal serum concentration (Cmax) of pegilodecakin is reported.
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin
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]
Time of maximum serum concentration (Tmax) of Pegilodecakin is reported.
PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin
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]
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
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]
Apparent total body clearance ((CL/F) is the volume of serum from which the drug is completely removed in a given time period.

Results and safety

Results posted to the registry on 7 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABC	4	4
Sequence BAC	4	4
Sequence CBA	4	4

Primary outcome: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin

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]. Geometric mean (Geometric Coefficient of Variation). Unit: picogram per milliliter (pg/mL)

Measure	Pegilodecakin: Treatment A n = 12	Pegilodecakin: Treatment B n = 11	Pegilodecakin: Treatment C n = 11
Body Weight ≤80 kg	8590 (51)	3820 (54)	4130 (81)
Body Weight >80 kg	18500 (97)	5970 (70)	11200 (25)

Population analysed: All randomized participants who received at least one dose of study drug and have evaluable PK data.

Primary outcome: PK: Time of Maximum Concentration (Tmax) of Pegilodecakin

Measure	Pegilodecakin: Treatment A n = 12	Pegilodecakin: Treatment B n = 11	Pegilodecakin: Treatment C n = 11
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)

Population analysed: All randomized participants who received at least one dose of study drug and have evaluable PK data.

Primary outcome: PK: Area Under the Concentration-Versus-Time Curve (AUC) of Pegilodecakin

Measure	Pegilodecakin: Treatment A n = 12	Pegilodecakin: Treatment B n = 11	Pegilodecakin: Treatment C n = 11
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)

Population analysed: All randomized participants who received at least one dose of study drug and have evaluable PK data.

Primary outcome: PK: Apparent Total Body Clearance of (CL/F) of Pegilodecakin

Measure	Pegilodecakin: Treatment A n = 12	Pegilodecakin: Treatment B n = 11	Pegilodecakin: Treatment C n = 11
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)

Population analysed: All randomized participants who received at least one dose of study drug and have evaluable PK data.

Adverse events

Time frame: Up To 22 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pegilodecakin: Treatment A	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Pegilodecakin: Treatment B	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Pegilodecakin: Treatment C	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pegilodecakin in people with Healthy Adult Subjects, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin (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]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03381547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.