Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT04194892
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2019-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial Formulations of AM0010 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Willow 3
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: