A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.

Official Title
-----------------
A Phase I, Double Blind, Placebo-controlled, Randomized, Parallel, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 Administered Subcutaneously in Healthy Japanese Subjects

Conditions
-----------------
Chronic Graft-versus-Host Disease (cGVHD)

Intervention / Treatment
-----------------
* Drug: AMG 592
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage) Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m^2 at the time of screening Exclusion Criteria: Participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ Participants with a known history of autoimmune disease Participants who have donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP Participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1 Positive for Hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B) Participant has positive test results for Human Immunodeficiency Virus (HIV) Participant has a positive test for tuberculosis during screening defined as either a positive purified derivative (PPD) (>= 5 mm of induration at 48 to 72 hours after test is placed) OR a positive QuantiFERON test

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: AMG 592 Dose 1<br>Participants will receive AMG 592 dose 1 subcutaneously | Drug: AMG 592<br>* Administered as SC injection<br>|
| Experimental: Arm 2: AMG 592 Dose 2<br>Participants will receive AMG 592 dose 2 subcutaneously | Drug: AMG 592<br>* Administered as SC injection<br>|
| Placebo Comparator: Arm 3: Placebo<br>Participants will receive placebo subcutaneously | Other: Placebo<br>* Administered as SC injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) of AMG 592 |  | Up to Day 43 | 
| Time of Maximum Observed Concentration (tmax) of AMG 592 |  | Up to Day 43 | 
| Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592 |  | Up to Day 43 | 
| Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf) |  | Up to Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) |  | Day 1 to Day 43 | 
| Number of Participants who Experience Anti-AMG 592 Antibodies Formation |  | Up to Day 43 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions