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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02596217 | Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers | PHASE1 | COMPLETED | 80 | — | — | Aug 1, 2015 | Jun 1, 2017 | Jul 6, 2017 | 2 | Japan, South Korea |
| Arm | Type | Description |
|---|---|---|
| Stage 1 (low dose SC) | EXPERIMENTAL | Low dose administered by subcutaneous (SC) injection |
| Stage 1 (medium dose SC) | EXPERIMENTAL | Medium dose administered by subcutaneous (SC) injection |
| Stage 1 (high dose SC) | EXPERIMENTAL | High dose administered by subcutaneous (SC) injection |
| Stage 2 (low dose IV) | EXPERIMENTAL | Low dose administered by intraveneous (IV) infusion |
| Stage 2 (medium dose IV) | EXPERIMENTAL | Medium dose administered by intraveneous (IV) infusion |
| Stage 2 (high dose IV) | EXPERIMENTAL | High dose administered by intraveneous (IV) infusion |
| Placebo SC (Stage1) | PLACEBO_COMPARATOR | Placebo administered by subcutaneous (SC) injection |
| Placebo IV (Stage2) | PLACEBO_COMPARATOR | Placebo administered by intraveneous (IV) infusion |
| Name | Type | Description |
|---|---|---|
| ABBV-066 | DRUG | SC injection |
| Placebo | DRUG | SC injection (stage 1) |
Inclusion criteria: 1. Healthy male subjects according to the investigator¿s assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests 2. Chinese ethnicity, Japanese ethnicity, or Caucasian according to the fol...