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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03267732
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Healthy Adult Subjects Biological: Pegilodecakin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : October 30, 2017

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267732


Locations
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United States, Texas
PPD Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
Eli Lilly and Company
ARMO BioSciences
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03267732    
Other Study ID Numbers: 17297
J1L-AM-JZGE ( Other Identifier: Eli Lilly and Company )
AM0010-801 ( Other Identifier: ARMO BioSciences )
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No