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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06148181 | A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants | PHASE1 | COMPLETED | 41 | — | — | Jan 29, 2024 | Dec 30, 2024 | Jan 23, 2025 | 1 | United States |
Cmax of ABBV-141 will be assessed.
Tmax of ABBV-141 will be assessed.
AUCt of ABBV-141 will be determined.
AUCinf of ABBV-141 will be assessed.
Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.
Dose normalized Cmax of ABBV-141 will be assessed.
Dose normalized AUC of ABBV-141 will be assessed.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1, ABBV-141 (Intravenous [IV]) | EXPERIMENTAL | Western participants will receive a single IV dose of ABBV-141. |
| Part 1, Placebo for ABBV-141 (IV) | PLACEBO_COMPARATOR | Western participants will receive a single IV dose of placebo for ABBV-141. |
| Part 1, ABBV-141 (subcutaneous [SC]) | EXPERIMENTAL | Western participants will receive a single SC dose of ABBV-141. |
| Part 1, Placebo for ABBV-141 (SC) | PLACEBO_COMPARATOR | Western participants will receive a single SC dose of placebo for ABBV-141. |
| Part 2, ABBV-141 (IV) | EXPERIMENTAL | Asian participants will receive a single IV dose of ABBV-141. |
| Part 2, Placebo for ABBV-141 (IV) | PLACEBO_COMPARATOR | Asian participants will receive a single IV dose of placebo for ABBV-141. |
| Part 2, ABBV-141 (SC) | EXPERIMENTAL | Asian participants will receive a single SC dose of ABBV-141. |
| Part 2, Placebo for ABBV-141 (SC) | PLACEBO_COMPARATOR | Asian participants will receive a single SC dose of placebo for ABBV-141. |
| Name | Type | Description |
|---|---|---|
| ABBV-141 | DRUG | Infusion; intravenous (IV) |
| Placebo for ABBV-141 | DRUG | Infusion; IV |
Inclusion Criteria: * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG). * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal. For Part 2 onl...