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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05603182 | A Study of PRA052 in Healthy Volunteers | PHASE1 | COMPLETED | 96 | — | — | Nov 7, 2022 | Feb 21, 2024 | Mar 7, 2024 | 1 | United States |
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| SAD Cohorts 1-8 Experimental Arm | EXPERIMENTAL | Subjects will receive a single intravenous or subcutaneous dose of PRA052 in a dose escalation format |
| SAD Cohorts 1-8 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive a single intravenous or subcutaneous dose of placebo |
| MAD Cohorts 1-5 Experimental Arm | EXPERIMENTAL | Subjects will receive three subcutaneous or intravenous doses of PRA052, one dose every 2 weeks, in a dose escalation format |
| MAD Cohorts 1-5 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive three subcutaneous or intravenous doses of placebo, one dose every 2 weeks |
| Name | Type | Description |
|---|---|---|
| PRA052 | DRUG | PRA052 |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 60 years of age. * Male subjects must use reliable forms of contraception during sexual intercourse with female partners ...