Trial comparing treatments for Inclisiran Formulation
Official title Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
ClinicalTrials.gov ID: NCT07626281
What this study is testing
What is Inclisiran 284 mg (PS80 formulation)?
An investigational once‑dose injectable medicine being studied for lowering LDL‑cholesterol in adults with high LDL‑C.
Also referred to as Inclisiran.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares the safety, how well the drug is tolerated, and how it moves through the body and works in the body between the current inclisiran product and a new version that contains polysorbate 80.
- Who it's for
- Adults who will receive a single 284‑mg subcutaneous injection of inclisiran.
- What's involved
- Participants will get one injection under the skin and will be monitored for side effects and blood changes after the dose.
- Time commitment
- The study involves one injection and follow‑up visits to check safety and blood results over a short period after the dose.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male and female (non-childbearing potential) participants between 18 and 60 years of age (inclusive) with fasting serum LDL-C between 100 and...
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening with a body weight of at least 50 kg.
You likely can't join if
- Participants with homozygous and heterozygous familial hypercholesterolemia will be excluded.
- Historical or current use of any statin (i.e. study participants must be statin naive), other oral LDL-C-lowering medication or supplements that in...
The study team makes the final eligibility decision.
Where it is enrolling
- Lenexa, Kansas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Lenexa, Kansas, United States; San Antonio, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.