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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2010-024363-40 |
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The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 0.25 mg/kg in Healthy Subjects |
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| Cohort 2 | Experimental | 0.5 mg/kg in Healthy Subjects |
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| Cohort 3 | Experimental | 1.0 mg/kg in Healthy Subjects |
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| Cohort 4 | Experimental | 1.5 mg/kg in Healthy Subjects |
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| Cohort 5 | Experimental | 2.0 mg/kg in Healthy Subjects |
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| Saline 0.9% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPC4955 | Drug | 3 Weekly SC injections |
| |
| SPC4955 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects experiencing adverse events | up to 78 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of SPC4955 | Up to 78 Days | |
| total Cholesterol | up to 78 days | |
| Area under the plasma concentration versus time curve (AUC) of SPC4955 |
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Inclusion Criteria:
Healthy male or female subjects, age 18-65 years, inclusive.
BMI 18-33 kg/m2
Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Feuerer, Dr. med. | Nuvisan GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | 89231 | Germany |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
3 Weekly SC injections |
|
| SPC4955 | Drug | 3 Weekly SC injections |
|
| SPC4955 | Drug | 3 Weekly SC injections |
|
| SPC4955 | Drug | 3 Weekly SC injections |
|
| Saline 0.9% | Drug | 3 Weekly SC injections |
|
| Up to 78 days |
| LDL | up to 78 days |
| HDL | up to 78 days |
| D017670 |
| Sodium Compounds |