Chronic Graft-versus-Host Disease (cGVHD)
Conditions
Keywords
Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions
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.
Interventions
DRUGAMG 592
Administered as SC injection
OTHERPlacebo
Administered as SC injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Australia
Outcome results
None listed