Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
- Summary
- The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a single 284 mg subcutaneous (SC) administration.
- Short title
- Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
- Official title
- A Randomized, Open-label, Single-dose, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inclisiran Containing Polysorbate 80 Versus Inclisiran Alone in Participants With Elevated Low-density Lipoprotein Cholesterol
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-12-21
- First posted
- 2026-06-04
- Registry last updated
- 2026-10-05
- Primary completion date
- 2026-12-21
- Start date
- 2026-06-09
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novartis Pharmaceuticals
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07626281
- ClinicalTrials.gov ID
- NCT07626281
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Primary plasma PK parameters: Cmax
Timeframe: Day 1, Day 2, Day 3 and Day 4
Cmax = maximum observed plasma concentration
Primary plasma PK parameters: AUClast
Timeframe: Day 1, Day 2, Day 3 and Day 4
AUClast = AUC from time zero to the last measurable concentration sampling time
Primary plasma PK parameters: AUCinf
Timeframe: Day 1, Day 2, Day 3 and Day 4
AUCinf = AUC from time zero to infinity
Additional PK parameters: AUC0-24hr
Timeframe: Day 1, Day 2, Day 3 and Day 4
AUC0-24hr = AUC from time zero to 24 hours
Additional PK parameters: Tmax
Timeframe: Day 1, Day 2, Day 3 and Day 4
Tmax = time to reach maximum plasma concentration
Additional PK parameters: T1/2
Timeframe: Day 1, Day 2, Day 3 and Day 4
T1/2 = elimination half-life
Additional PK parameters: CL/F
Timeframe: Day 1, Day 2, Day 3 and Day 4
CL/F = total body clearance
Additional PK parameters: Vz/F
Timeframe: Day 1, Day 2, Day 3 and Day 4
Vz/F = apparent volume of distribution
Number of participants with AEs
Timeframe: Up to Day 90
Number of participants with AEs, including abnormal vital signs, ECGs, injection site reactions and safety laboratory parameters.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- 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 lowering therapy.
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening with a body weight of at least 50 kg.
- 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 investigators' judgment may affect serum LDL-C levels.
Other protocol inclusion/exclusion criteria may apply
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