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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03822208 | First in Human Study for Safety and Tolerability of AL003. | PHASE1 | COMPLETED | 54 | — | — | Mar 29, 2019 | May 6, 2021 | Sep 17, 2021 | 6 | United States, Australia |
Incidence of adverse events during the treatment and follow up periods through out the study.
| Arm | Type | Description |
|---|---|---|
| AL003 by intravenous (IV) infusion | ACTIVE_COMPARATOR | Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in single cohort |
| Placebo by intravenous (IV) infusion | PLACEBO_COMPARATOR | Matching saline solution will be administered for placebo subjects |
| Name | Type | Description |
|---|---|---|
| AL003 | BIOLOGICAL | Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort |
| Saline Solution | OTHER | Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo |
Inclusion Criteria: 1. Total body weight between 50 and 120 kg, inclusive 2. Clinical laboratory evaluations (including chemistry panel fasted \[at least 8 hours\], complete blood count (CBC), and urine analysis) within the reference range for the test laboratory, unless deemed not clinically signi...