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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 drug being developed for elevated lipoprotein(a), a cardiovascular condition. It is designed to lower levels of lipoprotein(a) in patients with elevated levels. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
IONIS-APO-LRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for elevated lipoprotein(a).
IONIS-APO-LRx is in Phase 1 clinical development. A Phase 1 trial has been completed, involving 60 participants with elevated lipoprotein(a). The drug is investigational and has not received FDA approval, as it is still in the early stages of clinical testing.
IONIS-APO-LRx has one completed Phase 1 clinical trial registered as NCT02414594. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in healthy volunteers with elevated lipoprotein(a). The trial was randomized, double-blind, and placebo-controlled, enrolling 60 participants in Canada.
Yes, IONIS-APO-LRx is the same drug as IONIS APO(a)-LRx. The clinical trial NCT02414594 uses the name IONIS APO(a)-LRx to refer to the same investigational compound being developed by Ionis Pharmaceuticals for elevated lipoprotein(a).