A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)

Study Overview
=================
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.

Official Title
-----------------
A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Biological: Pegilodecakin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ | Biological: Pegilodecakin<br>* Pegilodecakin Alone<br>* Other names: AM0010;|
| Active Comparator: 2<br>Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ | Biological: Pegilodecakin<br>* Pegilodecakin Alone<br>* Other names: AM0010;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Evaluate the safety of single/multiple SQ doses of Pegilodecakin - Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, EKGs, and vital signs | 43 days |