A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants
Chronic Graft-versus-Host Disease (cGVHD)
About this trial
This is an interventional basic science trial for Chronic Graft-versus-Host Disease (cGVHD) focused on measuring Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Arm 1: AMG 592 Dose 1
Arm 2: AMG 592 Dose 2
Arm 3: Placebo
Participants will receive AMG 592 dose 1 subcutaneously
Participants will receive AMG 592 dose 2 subcutaneously
Participants will receive placebo subcutaneously