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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 APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IONIS-APO(a)-LRx | Experimental | Drug: IONIS-APO(a)-LRx |
|
| Placebo (Normal Saline) | Placebo Comparator | Drug: Sterile Normal Saline (0.9% NaCl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IONIS-APO(a)-LRx | Drug | Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single and multiple doses of IONIS-APO(a)-LRx (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters) | The safety and tolerability of IONIS-APO(a)-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-APO(a)-LRx will be compared with those from subjects dosed with placebo. | Up to 113 days |
| To evaluate the pharmacokinetics of single and multiple doses of IONIS-APO(a)-LRx (unconjugated and conjugated ASO) | The plasma pharmacokinetics of IONIS-APO(a)-LRx (unconjugated and conjugated ASO) will be assessed following single and multiple-dose SC administration. The amount of ISIS-APO(a)-LRx excreted in urine at selected 24-hour intervals will also be determined. | Up to 113 days |
| To evaluate the plasma pharmacodynamics of IONIS-APO(a)-LRx (Changes in plasma Lp(a) levels) | Changes in plasma Lp(a) levels compared to baseline. | Up to 113 days |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx | Effects of IONIS-APO(a)-LRx on changes in levels of oxidized phospholipids associated with apoB-100 compared to baseline. | Up to 113 days |
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Toronto | Ontario | M9L 3A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37070852 | Derived | Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429. | |
| 27665230 | Derived |
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| Sterile Normal Saline (0.9% NaCl) | Drug | Calculated volume to match active comparator |
|
Effects of IONIS-APO(a)-LRx on changes in levels of oxidized phospholipids associated with apo(a) compared to baseline. |
| Up to 113 days |
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx | Effects of IONIS-APO(a)-LRx on changes in Lp-PLA2 compared to baseline. | Up to 113 days |
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx | Effects of IONIS-APO(a)-LRx on changes in sPLA2 compared to baseline. | Up to 113 days |
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx | Effects of IONIS-APO(a)-LRx on changes in apo(a) isoform size compared to baseline. | Up to 113 days |
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx | Effects of ISIS-APO(a)-LRx on changes in lipid panel compared to baseline. | Up to 113 days |
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx | Effects of IONIS-APO(a)-LRx on changes in systemic markers of inflammation compared to baseline. | Up to 113 days |
| Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx | Effects of IONIS-APO(a)-LRx on changes in plasminogen/coagulation compared to baseline. | Up to 113 days |
| Viney NJ, van Capelleveen JC, Geary RS, Xia S, Tami JA, Yu RZ, Marcovina SM, Hughes SG, Graham MJ, Crooke RM, Crooke ST, Witztum JL, Stroes ES, Tsimikas S. Antisense oligonucleotides targeting apolipoprotein(a) in people with raised lipoprotein(a): two randomised, double-blind, placebo-controlled, dose-ranging trials. Lancet. 2016 Nov 5;388(10057):2239-2253. doi: 10.1016/S0140-6736(16)31009-1. Epub 2016 Sep 21. |