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

NCT04194892 | Completed Phase 1 FDA Drug

• 3 other identifiers: 17299J1L-AM-JZGGAM0010-803
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin

  Cmax of Pegilodecakin

  Predose through approximately 14 days postdose

• PK: Time of Maximum Concentration (Tmax)

  Tmax of Pegilodecakin

  Predose through approximately 14 days postdose

• PK: Area Under the Serum Concentration Versus Time Curve (AUC)

  AUC of Pegilodecakin

  Predose through approximately 14 days postdose

Study Arms (2)

Pegilodecakin Vial

EXPERIMENTAL

Pegilodecakin administered subcutaneously (SQ) in one of two study periods.

Biological: Pegilodecakin

Pegilodecakin Pre-filled syringe (PFS)

EXPERIMENTAL

Pegilodecakin administered SQ in one of two study periods.

Biological: Pegilodecakin

Interventions

Pegilodecakin BIOLOGICAL

Administered SQ

Also known as: LY3500518, AM0010

Pegilodecakin Pre-filled syringe (PFS); Pegilodecakin Vial

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ARMO BioSciences: collaborator

Study Sites (1)

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

pegilodecakin; AM0010

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 11, 2019
• Study Start: January 19, 2018
• Primary Completion: March 14, 2018
• Study Completion: March 14, 2018
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)