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The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| M281 | Experimental | M281 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M281 | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Counts and Percentages of adverse events by treatment group | Baseline until up-to 12 weeks post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of M281 will be summarized using descriptive statistics (arithmetic means, SDs, coefficients of variation, sample size, minimum, maximum, and geometric means). | Baseline up-to 12 weeks post-dose | |
| PD of M281 will summarize changes in serum markers of inflammation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hogan, MPM | Momenta Director of Clinical Operations | Study Director |
| Tjerk Bosji, MD | PRA Research Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Zuidlaren | Netherlands |
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| Up until 12 weeks post dose |