Clinical trial NCT05885451: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Graft-versus-Host Disease (cGVHD)
Keywords: Chronic Graft-versus-Host Disease
AMG 592
Inflammatory Conditions
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of AMG 592
timeFrame: Up to Day 43
measure: Time of Maximum Observed Concentration (tmax) of AMG 592
timeFrame: Up to Day 43
measure: Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
timeFrame: Up to Day 43
measure: Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)
timeFrame: Up to Day 43
Secondary outcomes:
measure: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 43
measure: Number of Participants who Experience Anti-AMG 592 Antibodies Formation
timeFrame: Up to Day 43
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Research Site
state: New South Wales
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: