A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
NCT ID: NCT04194892
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2018-01-19
2018-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Pegilodecakin Vial
Pegilodecakin administered subcutaneously (SQ) in one of two study periods.
Pegilodecakin
Administered SQ
Pegilodecakin Pre-filled syringe (PFS)
Pegilodecakin administered SQ in one of two study periods.
Pegilodecakin
Administered SQ
Interventions
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Pegilodecakin
Administered SQ
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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ARMO BioSciences
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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PPD Phase 1 Clinic
Austin, Texas, United States
Countries
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Other Identifiers
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J1L-AM-JZGG
Identifier Type: OTHER
Identifier Source: secondary_id
AM0010-803
Identifier Type: OTHER
Identifier Source: secondary_id
17299
Identifier Type: -
Identifier Source: org_study_id