Status:
COMPLETED
A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ARMO BioSciences
Conditions:
Healthy Adult Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
Detailed Description
An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
Eligibility Criteria
Inclusion
- Male or female between 18 and 55 years of age, inclusive
- Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
- Must be 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
- Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug.
- 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
- 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
- Have poor venous access and are unable to donate blood
- Have been vaccinated within 90 days of study dosing
- Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
- Have history of significant drug sensitivity or drug allergy.
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03381547
Start Date
December 18 2017
End Date
February 11 2018
Last Update
April 5 2019
Active Locations (1)
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1
PPD Development
Austin, Texas, United States, 78744