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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: AMG 592 Dose 1 | Experimental | Participants will receive AMG 592 dose 1 subcutaneously |
|
| Arm 2: AMG 592 Dose 2 | Experimental | Participants will receive AMG 592 dose 2 subcutaneously |
|
| Arm 3: Placebo | Placebo Comparator | Participants will receive placebo subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 592 | Drug | Administered as SC injection |
| |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Randwick | New South Wales | 2031 | Australia |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| Placebo |
| Other |
Administered as SC injection |
|
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |