Status:
COMPLETED
A 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 single and multiple doses of pegilodecakin in healthy participants.
Detailed Description
This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.
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
- 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 :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03267732
Start Date
September 5 2017
End Date
October 30 2017
Last Update
April 5 2019
Active Locations (1)
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1
PPD Development
Austin, Texas, United States, 78744