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Also known as IONIS-APO(a)-LRx
IONIS-APO-LRx · 1 trial · 1 indication
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.
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.
Changes in plasma Lp(a) levels compared to baseline.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| IONIS-APO(a)-LRx | DRUG | Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection |
| Sterile Normal Saline (0.9% NaCl) | DRUG | Calculated volume to match active comparator |
Inclusion Criteria: * Must have given written informed consent and be able to comply with all study requirements * Healthy males or females aged 18-65 inclusive and weighing ≥ 50 kg at the time of informed consent * Females must be non-pregnant and non-lactating, and either surgically sterile or po...
IONIS-APO-LRx is an investigational small molecule developed by Ionis Pharmaceuticals, Inc. (ticker: IONS) for elevated lipoprotein(a). It was studied in a Phase 1 clinical trial in healthy volunteers with elevated lipoprotein(a). The drug has not been approved and remains in clinical development.
IONIS-APO-LRx is being developed for elevated lipoprotein(a), a cardiovascular risk factor. It is an investigational therapy and has not been approved for any indication. The only completed clinical trial enrolled healthy volunteers with elevated lipoprotein(a) to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
IONIS-APO-LRx is developed by Ionis Pharmaceuticals, Inc., which trades under the ticker IONS. The company sponsored the Phase 1 trial of the drug in healthy volunteers with elevated lipoprotein(a). No other developer or partner is associated with this asset.
IONIS-APO-LRx is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA or any regulatory agency for elevated lipoprotein(a) or any other indication.
IONIS-APO-LRx has been studied in one completed Phase 1 trial, NCT02414594, titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS APO(a)-LRx in Healthy Volunteers With Elevated Lipoprotein(a)." The trial enrolled 60 participants in Canada and was randomized, double-blind, and placebo-controlled.
Yes, IONIS-APO-LRx is also known as IONIS-APO(a)-LRx. Both names refer to the same investigational drug developed by Ionis Pharmaceuticals, Inc. for elevated lipoprotein(a). The alternative name appears in the registered Phase 1 trial NCT02414594.