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NCT07626281 · ClinicalTrials.gov registry record · Phase 1
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT07626281 is a Phase 1 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 120 participants.
The verdict
NCT07626281, a Phase 1 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study 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.
Interventions
- DRUG Inclisiran formulation containing PS80
- DRUG Currently marketed inclisiran formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-06-09 |
| Est. Completion | 2026-12-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07626281
The ClinicalTrials.gov registry entry for NCT07626281 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Inclisiran formulation containing PS80 is the first listed.
NCT07626281 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07626281 about?
NCT07626281 is a clinical study titled "Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation". 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.
What is the current status of trial NCT07626281?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2026-06-09. Estimated completion is 2026-12-21.
What interventions are being tested in trial NCT07626281?
The interventions under investigation include: Inclisiran formulation containing PS80 (DRUG), Currently marketed inclisiran formulation (DRUG).
Who is sponsoring clinical trial NCT07626281?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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