Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07626281 | Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation | PHASE1 | NOT YET_RECRUITING | 120 | — | — | Jun 15, 2026 | Dec 21, 2026 | Jun 4, 2026 | - | — |
Cmax = maximum observed plasma concentration
AUClast = AUC from time zero to the last measurable concentration sampling time
AUCinf = AUC from time zero to infinity
AUC0-24hr = AUC from time zero to 24 hours
Tmax = time to reach maximum plasma concentration
T1/2 = elimination half-life
CL/F = total body clearance
Vz/F = apparent volume of distribution
| Arm | Type | Description |
|---|---|---|
| Arm A (inclisiran - currently marketed formulation) | ACTIVE_COMPARATOR | Inclisiran 284 mg × 1 single dose on Day 1 |
| Arm B (inclisiran - formulation containing PS80) | EXPERIMENTAL | Inclisiran 284 mg × 1 single dose on Day 1 |
| Name | Type | Description |
|---|---|---|
| Inclisiran formulation containing PS80 | DRUG | Inclisiran 284 mg |
| Currently marketed inclisiran formulation | DRUG | Inclisiran 284 mg |
Inclusion Criteria: * 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 l...