A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants (Willow 3)

December 10, 2019 updated by: Eli Lilly and Company

An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial Formulations of AM0010 in Healthy Adult Subjects

The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Phase 1 Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening
  • Must be Human Immunodeficiency Virus (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

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
  • Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
  • Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing
  • Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
  • Have been vaccinated within 90 days of study dosing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pegilodecakin Vial
Pegilodecakin administered subcutaneously (SQ) in one of two study periods.
Biological: Pegilodecakin
Administered SQ
Other Names:
  • LY3500518
  • AM0010
EXPERIMENTAL: Pegilodecakin Pre-filled syringe (PFS)
Pegilodecakin administered SQ in one of two study periods.
Biological: Pegilodecakin
Administered SQ
Other Names:
  • LY3500518
  • AM0010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
Time Frame: Predose through approximately 14 days postdose
Cmax of Pegilodecakin
Predose through approximately 14 days postdose
PK: Time of Maximum Concentration (Tmax)
Time Frame: Predose through approximately 14 days postdose
Tmax of Pegilodecakin
Predose through approximately 14 days postdose
PK: Area Under the Serum Concentration Versus Time Curve (AUC)
Time Frame: Predose through approximately 14 days postdose
AUC of Pegilodecakin
Predose through approximately 14 days postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

ARMO BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 19, 2018

Primary Completion (ACTUAL)

March 14, 2018

Study Completion (ACTUAL)

March 14, 2018

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (ACTUAL)

December 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 17299
  • J1L-AM-JZGG (OTHER: Eli Lilly and Company)
  • AM0010-803 (OTHER: 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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