Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APOC-III-L-Rx · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| APOC-III-L-Rx | DRUG | Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection |
| Placebo Comparator | DRUG | Sterile Normal Saline (0.9% NaCl) 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 * Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal * Males must be surgically sterile, ab...
APOC-III-L-Rx is an investigational drug being developed for the treatment of elevated triglycerides (TG). It is a small molecule being studied in a Phase 1 clinical trial. The drug is intended to address high levels of triglycerides, a type of fat in the blood that can increase the risk of cardiovascular disease.
APOC-III-L-Rx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company. Ionis Pharmaceuticals is listed on the NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for elevated triglycerides.
APOC-III-L-Rx is currently in Phase 1 of clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing to assess its safety, tolerability, and pharmacological effects.
APOC-III-L-Rx has been studied in one completed Phase 1 clinical trial with the identifier NCT02900027. The trial was titled 'Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides.' It enrolled 56 participants in Canada and was a randomized, double-blind, placebo-controlled study.
Yes, APOC-III-L-Rx is also known as IONIS APOCIII-LRx. In the clinical trial records, the drug is referred to as IONIS APOCIII-LRx, and APOC-III-L-Rx is the name used for the drug in development. Both names refer to the same investigational compound being developed by Ionis Pharmaceuticals.