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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021948-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Ionis Pharmaceuticals, Inc. | INDUSTRY |
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This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50, mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will receive a single study injection of either mipomersen or placebo. Subjects will be enrolled into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design. Dose-escalation will proceed only if there is an acceptable safety profile from the previous dosing level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mipomersen | Experimental | 50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) SC single dose |
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| placebo | Placebo Comparator | 50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) SC single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mipomersen | Drug | 50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) subcutaneous (SC) single dose of study drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | plasma PK parameters | Baseline up to Day 36 Post-Treatment |
| Time to maximal concentration (Tmax) | plasma PK parameters | Baseline up to Day 36 Post-Treatment |
| Area Under the Curve (AUC) | plasma PK parameters | Baseline up to Day 36 Post-Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 36 Post-Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FOCUS Clinical Drug Development GmbH | Stresemannallee 6, Neuss | 41460 | Germany |
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| ID | Term |
|---|---|
| C524142 | mipomersen |
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| placebo | Drug | 50 mg (cohort A), 100mg (cohort B), or 200mg (cohort C) subcutaneous (SC) single dose of study drug |
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