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

NCT05885451 | Completed Phase 1 FDA Drug

• 1 other identifier: 20180132
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Graft-versus-Host Disease (cGVHD)

Keywords

Chronic Graft-versus-Host Disease; AMG 592; Inflammatory Conditions

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (3)

Arm 1: AMG 592 Dose 1

EXPERIMENTAL

Participants will receive AMG 592 dose 1 subcutaneously

Drug: AMG 592

Arm 2: AMG 592 Dose 2

EXPERIMENTAL

Participants will receive AMG 592 dose 2 subcutaneously

Drug: AMG 592

Arm 3: Placebo

PLACEBO COMPARATOR

Participants will receive placebo subcutaneously

Other: Placebo

Interventions

AMG 592 DRUG

Administered as SC injection

Arm 1: AMG 592 Dose 1; Arm 2: AMG 592 Dose 2

Placebo OTHER

Administered as SC injection

Arm 3: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Research Site

Randwick, New South Wales, 2031, Australia

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: January 29, 2019
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: June 2, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

AU (1)