A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)

NCT03267732 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 17297J1L-AM-JZGEAM0010-801
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (8)

• 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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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)

Study Arms (2)

Pegilodecakin (5 μg/kg)

EXPERIMENTAL

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

Pegilodecakin (10 μg/kg)

EXPERIMENTAL

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

Interventions

Pegilodecakin BIOLOGICAL

Administered SQ

Also known as: LY3500518, AM0010

Pegilodecakin (10 μg/kg); Pegilodecakin (5 μg/kg)

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
• 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 30, 2017
• Study Start: September 5, 2017
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: October 2, 2026
• Results First Posted: October 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)