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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04194892
Collaborator
ARMO BioSciences (Industry)
12
Enrollment
1
Location
2
Arms
1.8
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Pegilodecakin
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Jan 19, 2018
Actual Primary Completion Date :
Mar 14, 2018
Actual Study Completion Date :
Mar 14, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin [Predose through approximately 14 days postdose]

      Cmax of Pegilodecakin

    2. PK: Time of Maximum Concentration (Tmax) [Predose through approximately 14 days postdose]

      Tmax of Pegilodecakin

    3. PK: Area Under the Serum Concentration Versus Time Curve (AUC) [Predose through approximately 14 days postdose]

      AUC of Pegilodecakin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PPD Phase 1 Clinic Austin Texas United States 78744

    Sponsors and Collaborators

    • Eli Lilly and Company
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04194892
    Other Study ID Numbers:
    • 17299
    • J1L-AM-JZGG
    • AM0010-803
    First Posted:
    Dec 11, 2019
    Last Update Posted:
    Dec 11, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 11, 2019