Clinical Trials/NCT05885451

NCT05885451

Completed

Phase 1

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

Amgen1 site in 1 country18 target enrollmentJanuary 29, 2019

ConditionsChronic Graft-versus-Host Disease (cGVHD)

InterventionsAMG 592 Placebo

DrugsAMG 592

Overview

Phase: Phase 1
Intervention: AMG 592
Conditions: Chronic Graft-versus-Host Disease (cGVHD)
Sponsor: Amgen
Enrollment: 18
Locations: 1
Primary Endpoint: Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 29, 2019

End Date

April 11, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

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

Arms & Interventions

Arm 1: AMG 592 Dose 1

Participants will receive AMG 592 dose 1 subcutaneously

Intervention: AMG 592

Arm 2: AMG 592 Dose 2

Participants will receive AMG 592 dose 2 subcutaneously

Intervention: AMG 592

Arm 3: Placebo

Participants will receive placebo subcutaneously

Intervention: Placebo

Outcomes

Primary Outcomes

Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592

Time Frame: Up to Day 43

Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)

Time Frame: Up to Day 43

Maximum Observed Serum Concentration (Cmax) of AMG 592

Time Frame: Up to Day 43

Time of Maximum Observed Concentration (tmax) of AMG 592

Time Frame: Up to Day 43

Secondary Outcomes

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)