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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Graft-versus-Host Disease (cGVHD)
• Intervention / Treatment: Drug: AMG 592; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): April 11, 2019
• Study Completion (Actual): April 11, 2019

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Estimated): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: AMG 592; Chronic Graft-versus-Host Disease; Inflammatory Conditions
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis Obliterans; Bronchiolitis; Organizing Pneumonia; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome
• Other Study ID Numbers: 20180132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No