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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Pegilodecakin

• Registration Number: NCT04194892
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-19
• Primary Completion: 2018-03-14
• Study Completion: 2018-03-14
• Status Verified: 2019-12
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pegilodecakin Pre-filled syringe (PFS)	Pegilodecakin	Pegilodecakin administered SQ in one of two study periods.
Pegilodecakin Vial	Pegilodecakin	Pegilodecakin administered subcutaneously (SQ) in one of two study periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin	Predose through approximately 14 days postdose	Cmax of Pegilodecakin
PK: Time of Maximum Concentration (Tmax)	Predose through approximately 14 days postdose	Tmax of Pegilodecakin
PK: Area Under the Serum Concentration Versus Time Curve (AUC)	Predose through approximately 14 days postdose	AUC of Pegilodecakin

Trial Locations

Locations (1)

PPD Phase 1 Clinic; 🇺🇸 Austin, Texas, United States