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Completed

NCT Number: NCT03381547

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

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

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development

Austin, Texas, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Pegilodecakin

Biological

Pegilodecakin alone administered SQ

Other names: LY3500518, AM0010

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ARMO BioSciences

Registry information

Official study 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

Acronym: Willow 2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2017
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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