A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)

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

Official Title
-----------------
An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations 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 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 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Pegilodecakin: Dose level depending on weight will be 0.8 mg or 1.6 mg, dose formulation 4 mg/mL. | Biological: Pegilodecakin<br>* Pegilodecakin Alone<br>* Other names: AM0010;|
| Active Comparator: B<br>Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 4 mg/mL. | Biological: Pegilodecakin<br>* Pegilodecakin Alone<br>* Other names: AM0010;|
| Active Comparator: C<br>Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 2 mg/mL. | 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) | Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, and vital signs. | 43 days |