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

NCT03381547 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 17298J1L-AM-JZGFAM0010-802
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (4)

• 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]

Study Arms (3)

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.

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.

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.

Biological: Pegilodecakin

Interventions

Pegilodecakin BIOLOGICAL

Pegilodecakin alone administered SQ

Also known as: LY3500518, AM0010

Pegilodecakin: Treatment A; Pegilodecakin: Treatment B; Pegilodecakin: Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ARMO BioSciences: collaborator

Study Sites (1)

PPD Development

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

pegilodecakin; AM0010

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 22, 2017
• Study Start: December 18, 2017
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: July 7, 2026
• Results First Posted: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)