A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) (Willow 2)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Biological: Pegilodecakin

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegilodecakin: Treatment A; 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; Pegilodecakin alone administered SQ; Other Names: LY3500518; AM0010
Experimental: Pegilodecakin: Treatment B; 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; Pegilodecakin alone administered SQ; Other Names: LY3500518; AM0010
Experimental: Pegilodecakin: Treatment C; 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; Other Names: LY3500518; AM0010

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin	Maximal serum concentration (Cmax) of pegilodecakin is reported.	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.	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.	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.	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]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, and vital signs.	43 days

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: ARMO BioSciences
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): February 13, 2018
• Study Completion (Actual): February 13, 2018

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: pegilodecakin; AM0010
• Other Study ID Numbers: 17298; J1L-AM-JZGF (Other Identifier: Eli Lilly and Company); AM0010-802 (Other Identifier: ARMO BioSciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No