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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07612020 | A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants | PHASE1 | RECRUITING | 130 | — | — | Mar 16, 2026 | Oct 1, 2027 | May 28, 2026 | 1 | Canada |
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Ctrough = trough concentration
| Arm | Type | Description |
|---|---|---|
| Open-label treatment period (part A): empasiprubart SC AI (via abdomen) | EXPERIMENTAL | Participants randomized to receive empasiprubart SC AI via abdomen. |
| Open-label treatment period (part A): empasiprubart SC AI (via thigh) | EXPERIMENTAL | Participants randomized to receive empasiprubart SC AI via thigh. |
| Open-label treatment period (part A): empasiprubart IV | EXPERIMENTAL | Participants randomized to receive empasiprubart IV. |
| Open-label treatment period (part B): empasiprubart SC AI | EXPERIMENTAL | Participants randomized to receive empasiprubart IV and empasiprubart SC AI. |
| Open-label treatment period (part B): empasiprubart IV | EXPERIMENTAL | Participants randomized to receive empasiprubart IV. |
| Name | Type | Description |
|---|---|---|
| empasiprubart SC AI | BIOLOGICAL | Subcutaneous injection of empasiprubart via Autoinjector (AI). |
| empasiprubart IV | BIOLOGICAL | Intravenous infusion of empasiprubart |
Inclusion Criteria: * Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF. * Has a body weight between 50 and 120 kg and a BMI between 18 and 35 kg/m2, inclusive. Exclusion Criteria: * Has any current or past clinically meaningful medical or psychia...