A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Willow 1
A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects
3 other identifiers
interventional
24
1 country
1
Brief Summary
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedApril 5, 2019
April 1, 2019
2 months
August 24, 2017
April 3, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Pharmacokinetic parameters, Cmax
maximal plasma concentration (Cmax)
43 days
Pharmacokinetic parameters, Tmax
maximal concentration (Tmax)
43 days
Pharmacokinetic parameters, AUC
area under the plasma concentration curve (AUC)
43 days
Pharmacokinetic parameters, CL/F
clearance (CL/F).
43 days
Secondary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
43 days
Study Arms (2)
1
ACTIVE COMPARATORPegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ
2
ACTIVE COMPARATORPegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ
Interventions
Eligibility Criteria
You may qualify if:
- 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
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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- ARMO BioSciencescollaborator
Study Sites (1)
PPD Development
Austin, Texas, 78744, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2017
First Posted
August 30, 2017
Study Start
September 5, 2017
Primary Completion
October 30, 2017
Study Completion
October 30, 2017
Last Updated
April 5, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share