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The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to Healthy Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donidalorsen | Experimental | Ascending single and multiple doses of Donidalorsen administered subcutaneously |
|
| Placebo (sterile saline 0.9%) | Placebo Comparator | Calculated volume to match active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Saline .9% |
| |
| Donidalorsen |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events that are related to treatment with Donidalorsen | The safety and tolerability of multiple doses of Donidalorsen will be assessed by determining the incidence, severity, and dose relationship of adverse events that are related to treatment with Donidalorsen. | Up to 176 days |
| Peak plasma Concentration (Cmax) of Donidalorsen | Maximum Donidalorsen plasma concentration, Cmax (ug/mL) will be assessed following SC administration | Up to 176 days |
| Time to peak plasma Concentration (Tmax) of Donidalorsen | Time to peak Donidalorsen plasma concentration, Tmax (hours) will be assessed following SC administration | Up to 176 days |
| Effects of Donidalorsen on plasma PKK concentration | Effects of Donidalorsen on plasma PKK concentration after multiple doses of Donidalorsen compared to baseline | Up to 176 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ionis Investigative Site | Toronto | Ontario | M9L 3A2 | Canada |
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| ID | Term |
|---|---|
| C000723381 | donidalorsen |
| C000711268 | IONIS-PKK-LRx |
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| Drug |
Donidalorsen administered subcutaneously |
|
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