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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05354349 | Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023 | PHASE1 | COMPLETED | 49 | — | — | Apr 6, 2022 | Aug 31, 2022 | Jan 16, 2024 | 1 | United States |
| NCT04676178 | A Study of PRA023 in Healthy Volunteers | PHASE1 | COMPLETED | 69 | — | — | Dec 15, 2020 | Sep 23, 2021 | Jan 17, 2024 | 1 | United States |
Mean SC versus IV AUC(inf) values
Maximum concentration after single dose
Time to reach maximum concentration after single dose
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| PRA023 SC/Placebo IV | EXPERIMENTAL | Participants randomized to receive active subcutaneous injection/placebo intravenous infusion |
| Placebo SC/PRA023 IV Low Dose | ACTIVE_COMPARATOR | Participants randomized to receive placebo subcutaneous injection/active intravenous infusion |
| Placebo SC/Placebo IV | PLACEBO_COMPARATOR | Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion |
| Placebo SC/PRA023 IV High Dose | EXPERIMENTAL | - |
| SAD Cohorts 1-6 Experimental Arm | EXPERIMENTAL | Subjects will receive single intravenous doses of PRA023 in a dose escalation format |
| SAD Cohorts 1-6 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive intravenous doses of placebo |
| MAD Cohorts 1-5 Experimental Arm | EXPERIMENTAL | Subjects will receive three intravenous doses of PRA023, one dose every 2 weeks, in a dose escalation format |
| MAD Cohorts 1-5 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive three intravenous doses of placebo, one dose every 2 weeks, |
| Name | Type | Description |
|---|---|---|
| PRA023 IV Low Dose | DRUG | Drug |
| PRA023 SC | DRUG | Drug |
| Placebo IV | DRUG | Placebo |
| Placebo SC | DRUG | Placebo |
| PRA023 IV High Dose | DRUG | Drug |
| PRA023 | DRUG | PRA023 |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Subjects are required to meet the following criteria in order to be included in the study: 1. Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin. 2. Caucasian subjects must be of European or Latin American descent (i.e....