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Completed

NCT Number: NCT03267732

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

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

This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.

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
  • 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

Other names: LY3500518, AM0010

Primary outcomes

  1. Pharmacokinetic parameters, Cmax

    Time frame: 43 days

    maximal plasma concentration (Cmax)

  2. Pharmacokinetic parameters, Tmax

    Time frame: 43 days

    maximal concentration (Tmax)

  3. Pharmacokinetic parameters, AUC

    Time frame: 43 days

    area under the plasma concentration curve (AUC)

  4. Pharmacokinetic parameters, CL/F

    Time frame: 43 days

    clearance (CL/F).

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: 43 days

    Evaluate the safety of single/multiple SQ doses of Pegilodecakin - Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, EKGs, and vital signs

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ARMO BioSciences

Registry information

Official study title

A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects

Acronym: Willow 1

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2017
Registry last updated
Apr 5, 2019

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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