Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation

Conditions

• Inclisiran Formulation

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Inclisiran formulation containing PS80 — DRUG
  Inclisiran 284 mg
• Currently marketed inclisiran formulation — DRUG
  Inclisiran 284 mg

Study Details

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.

Key Dates

First listed

Jun 4, 2026

Start date

Jun 9, 2026

Status verified

Jul 2026

Primary completion

Dec 21, 2026

Completion

Dec 21, 2026

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (inclisiran - currently marketed formulation)
  Inclisiran 284 mg × 1 single dose on Day 1
• Experimental: Arm B (inclisiran - formulation containing PS80)
  Inclisiran 284 mg × 1 single dose on Day 1

Primary Outcome Measure

Primary plasma PK parameters: Cmax [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals

Locations (3)

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