Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inclisiran formulation containing PS80 · 1 trial · 1 indication
Cmax = maximum observed plasma concentration
AUClast = AUC from time zero to the last measurable concentration sampling time
AUCinf = AUC from time zero to infinity
AUC0-24hr = AUC from time zero to 24 hours
Tmax = time to reach maximum plasma concentration
T1/2 = elimination half-life
CL/F = total body clearance
Vz/F = apparent volume of distribution
| Arm | Type | Description |
|---|---|---|
| Arm A (inclisiran - currently marketed formulation) | ACTIVE_COMPARATOR | Inclisiran 284 mg × 1 single dose on Day 1 |
| Arm B (inclisiran - formulation containing PS80) | EXPERIMENTAL | Inclisiran 284 mg × 1 single dose on Day 1 |
| Name | Type | Description |
|---|---|---|
| Inclisiran formulation containing PS80 | DRUG | Inclisiran 284 mg |
| Currently marketed inclisiran formulation | DRUG | Inclisiran 284 mg |
Inclusion Criteria: * Healthy male and female (non-childbearing potential) participants between 18 and 60 years of age (inclusive) with fasting serum LDL-C between 100 and 189 mg/dL (2.6 to 4.89 mmol/L) and fasting triglyceride \<400 mg/dL (\<4.52 mmol/L) that are not on statin or any other lipid l...
Inclisiran formulation containing PS80 is an investigational new formulation of inclisiran, a small interfering RNA (siRNA) therapy. It is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics compared to the currently marketed formulation of inclisiran. The drug is in Phase 1 clinical development.
Inclisiran formulation containing PS80 is a small interfering RNA (siRNA) that targets the liver to reduce levels of PCSK9, a protein that regulates LDL cholesterol. By silencing PCSK9 production, it aims to lower low-density lipoprotein cholesterol. This new formulation includes polysorbate 80 (PS80) as an excipient.
Inclisiran formulation containing PS80 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 1 clinical trial to evaluate this new formulation of inclisiran.
Inclisiran formulation containing PS80 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics.
Inclisiran formulation containing PS80 is being studied in a single Phase 1 clinical trial with the identifier NCT07626281. The trial is titled 'Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation.' It is recruiting 120 participants in the United States.
Inclisiran formulation containing PS80 is a new formulation of the drug inclisiran, which is an siRNA therapy. The key difference is the addition of polysorbate 80 (PS80), an excipient, to the formulation. The Phase 1 trial is comparing this new formulation to the currently marketed version of inclisiran.