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The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants in this cohort will receive dose 1 of Fasinumab or placebo |
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| Cohort 2 | Experimental | Participants in this cohort will receive dose 2 of Fasinumab or placebo |
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| Cohort 3 | Experimental | Participants in this cohort will receive dose 3 of Fasinumab or placebo |
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| Cohort 4 | Experimental | Participants in this cohort will receive dose 4 of Fasinumab or placebo |
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| Cohort 5 | Experimental | Participants in this cohort will receive dose 5 of Fasinumab or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasinumab | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo. | Baseline to week 16 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasinumab serum concentrations over time | Baseline to week 16 (End of Study) | |
| Presence of anti-fasinumab antibodies over time | Baseline to week 16 (End of Study) |
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Key Inclusion Criteria:
Healthy male or female Japanese and Caucasian volunteers ≥20 and ≤55 years of age at the screening visit
Japanese subjects must:
Caucasian subjects must be Caucasian of European or Latin American descent
Have a Body Mass Index (BMI) ≤ 35
Be willing to refrain from taking NSAID medications (oral or topical) for 1 week prior to receiving study drug and for 16 weeks after study drug administration
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | United States |
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| ID | Term |
|---|---|
| C000626997 | fasinumab |
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| Placebo | Drug |
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