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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07545226 | Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose. | PHASE1 | NOT YET_RECRUITING | 400 | — | — | Apr 20, 2026 | Sep 8, 2026 | Apr 22, 2026 | - | — |
| NCT07422285 | Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose | PHASE1 | RECRUITING | 400 | — | — | Jan 16, 2026 | Jun 30, 2026 | Apr 16, 2026 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Evolocumab Drug Substance A (Test) | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. |
| Evolocumab Drug Substance B (Reference) | EXPERIMENTAL | Participants will receive a single SC dose of evolocumab drug substance B. |
| Evolocumab Drug Substance A | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. |
| Evolocumab Drug Substance B | EXPERIMENTAL | Participants will receive a single SC dose of evolocumab drug substance B. |
| Name | Type | Description |
|---|---|---|
| Evolocumab Drug Substance A (Test) | DRUG | Evolocumab drug substance A will be administered SC. |
| Evolocumab Drug Substance B (Reference) | DRUG | Evolocumab drug substance B will be administered SC. |
| Evolocumab Drug Substance A | DRUG | Evolocumab drug substance A will be administered SC. |
| Evolocumab Drug Substance B | DRUG | Evolocumab drug substance B will be administered SC. |
Inclusion Criteria: 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive. 3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening. Exclu...