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The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 592: Dose 1 | Experimental | Administered as a single dose subcutaneous (SC) injection. |
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| AMG 592: Dose 2 | Experimental | Administered as a single dose SC injection. |
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| AMG 592: Dose 3 | Experimental | Administered as a single dose SC injection. |
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| AMG 592: Dose 4 | Experimental | Administered as a single dose SC injection. |
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| AMG 592: Dose 5 | Experimental | Administered as a single dose SC injection. |
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| AMG 592: Dose 6 | Experimental | Administered as a single dose SC injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 592 | Drug | Administered as SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs. | Day 1 up to Day 57 |
| Number of Participants with Anti-AMG 592 Antibodies | Day 1 up to Day 57 | |
| Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs) | One week after AMG 592 administration (up to 7 days) | |
| Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons) | One week after AMG 592 administration (up to 7 days) | |
| Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs) | One week after AMG 592 administration (up to 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of AMG 592 | Day 1 up to Day 57 | |
| Time of Maximum Observed Concentration (tmax) of AMG 592 | Day 1 up to Day 57 | |
| Area Under the Concentration-time Curve (AUC) of AMG 592 |
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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 | Aventura | Florida | 33180 | United States |
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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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| AMG 592: Dose 7 | Experimental | Administered as a single dose SC injection. |
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| AMG 592: Dose 8 | Experimental | Administered as a single dose SC injection. |
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| Placebo | Placebo Comparator | Administered as SC injection. |
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| Placebo | Other | Administered as SC injection |
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| Day 1 up to Day 57 |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |