A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) (Willow 1)

April 3, 2019 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

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

    • Texas
      • Austin, Texas, United States, 78744
        • Ppd Development

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:

  1. Male or female between 18 and 55 years of age, inclusive
  2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
  3. Must be HIV negative by HIV 1/0/2 testing
  4. Must be Hepatitis B (HBV) surface antigen negative
  5. Must be Hepatitis C (HCV) antibody negative
  6. Females must have a negative serum pregnancy test
  7. 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:

  1. Pregnant or lactating subjects
  2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
  3. Have poor venous access and are unable to donate blood
  4. Have been vaccinated within 90 days of study dosing
  5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
  6. Have history of significant drug sensitivity or drug allergy.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ
Pegilodecakin Alone
Other Names:
  • LY3500518
  • AM0010
Active Comparator: 2
Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ
Pegilodecakin Alone
Other Names:
  • LY3500518
  • AM0010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters, Cmax
Time Frame: 43 days
maximal plasma concentration (Cmax)
43 days
Pharmacokinetic parameters, Tmax
Time Frame: 43 days
maximal concentration (Tmax)
43 days
Pharmacokinetic parameters, AUC
Time Frame: 43 days
area under the plasma concentration curve (AUC)
43 days
Pharmacokinetic parameters, CL/F
Time Frame: 43 days
clearance (CL/F).
43 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
43 days

Collaborators and Investigators

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

Collaborators

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)

September 5, 2017

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 17297
  • J1L-AM-JZGE (Other Identifier: Eli Lilly and Company)
  • AM0010-801 (Other Identifier: 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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