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

Primary Purpose

Chronic Graft-versus-Host Disease (cGVHD)

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
AMG 592
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1: AMG 592 Dose 1

Arm 2: AMG 592 Dose 2

Arm 3: Placebo

Arm Description

Participants will receive AMG 592 dose 1 subcutaneously

Participants will receive AMG 592 dose 2 subcutaneously

Participants will receive placebo subcutaneously

Outcomes

Primary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of AMG 592
Time of Maximum Observed Concentration (tmax) of AMG 592
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)

Secondary Outcome Measures

Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Number of Participants who Experience Anti-AMG 592 Antibodies Formation

Full Information

First Posted
May 23, 2023
Last Updated
May 23, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05885451
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
April 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft-versus-Host Disease (cGVHD)
Keywords
Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: AMG 592 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive AMG 592 dose 1 subcutaneously
Arm Title
Arm 2: AMG 592 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive AMG 592 dose 2 subcutaneously
Arm Title
Arm 3: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo subcutaneously
Intervention Type
Drug
Intervention Name(s)
AMG 592
Intervention Description
Administered as SC injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered as SC injection
Primary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax) of AMG 592
Time Frame
Up to Day 43
Title
Time of Maximum Observed Concentration (tmax) of AMG 592
Time Frame
Up to Day 43
Title
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
Time Frame
Up to Day 43
Title
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)
Time Frame
Up to Day 43
Secondary Outcome Measure Information:
Title
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Time Frame
Day 1 to Day 43
Title
Number of Participants who Experience Anti-AMG 592 Antibodies Formation
Time Frame
Up to Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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