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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: Recruiting Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT07626281 is a Phase 1 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax = maximum observed plasma concentration
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 |
What NCT07626281 shows while recruiting
NCT07626281 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 2 interventions - of which Inclisiran formulation containing PS80 is the first listed.
NCT07626281 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07626281's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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