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| Name | Class |
|---|---|
| Akcea Therapeutics | INDUSTRY |
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The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APOC-III-LRx given to healthy volunteer subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IONIS-APOC-III-LRx | Experimental | Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection |
|
| Placebo (Normal Saline) | Placebo Comparator | Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APOC-III-L-Rx | Drug | Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single and multiple doses of IONIS- APOC-III-LRx - (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters) | The safety and tolerability of IONIS- APOC-III-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse effects and changes in the laboratory parameters by dose. Safety results in subjects dosed with IONIS APOC-III-LRx will be compared with those from subjects dosed with placebo. | Up to 183 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx | The maximum area under the curve (AUC) of IONIS- APOC-III-LRx will be assessed following single and multiple- dose SC administration | Up to 183 days |
| To evaluate the urine pharmacokinetics of single and multiple doses of IONIS¬-APOC-III-LRx |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx | Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with plasma apolipoprotein C-III (apoC-III) compared to baseline. | Up to 183 days |
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Faulknor | BioPharma Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioPharma Services | Toronto | Ontario | M9L 3A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31329855 | Derived | Alexander VJ, Xia S, Hurh E, Hughes SG, O'Dea L, Geary RS, Witztum JL, Tsimikas S. N-acetyl galactosamine-conjugated antisense drug to APOC3 mRNA, triglycerides and atherogenic lipoprotein levels. Eur Heart J. 2019 Sep 1;40(33):2785-2796. doi: 10.1093/eurheartj/ehz209. |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo Comparator | Drug | Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator |
|
The amount of IONIS-APOC-III-LRx excreted in urine at selected 24-hour intervals [Ae0-24h] will be determined. |
| Up to 183 days |
| To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx | The maximum plasma concentration (Cmax) of IONIS- APOC-III-LRx will be assessed following single and multiple- dose SC administration | Up to 183 Days |
| To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx | The maximum time to Cmax (Tmax) of IONIS- APOC-III-LRx will be assessed following single and multiple-dose SC administration | Up to 183 days |
Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with TG compared to baseline. |
| Up to 183 days |
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx | Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with total cholesterol (TC) compared to baseline. | Up to 183 days |
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx | Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with low density lipoprotein cholesterol (LDL-C) compared to baseline. | Up to 183 days |
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx | Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with high density lipoprotein cholesterol (HDL-C) compared to baseline. | Up to 183 days |
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx | Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with non-high density lipoprotein cholesterol (non-HDL-C) compared to baseline. | Up to 183 days |
| Exploratory pharmacodynamic effects of IONIS-APOC-III-LRx | Effects of IONIS-APOC-III-LRx on changes in levels of oxidized phospholipids associated with very low density lipoprotein cholesterol (VLDL-C) compared to baseline. | Up to 183 days |
| D009750 |
| Nutritional and Metabolic Diseases |