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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04111666 | A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101 | PHASE1 | COMPLETED | 88 | — | — | Dec 14, 2019 | Jun 9, 2022 | Aug 10, 2022 | 2 | United States |
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
| Arm | Type | Description |
|---|---|---|
| AL101 IV | EXPERIMENTAL | * Up to four single ascending doses (SAD IV cohorts) * Multiple doses of AL101 administered IV (MD IV cohort) |
| Saline Solution | PLACEBO_COMPARATOR | Saline solution will be administered with the following: * Single IV infusion for four single ascending doses (SAD IV cohorts) in a ratio of 8 active and 3 placebo subjects * Multiple IV infusions for the MD IV cohort in a ratio of 8 active and 2 placebo subjects |
| AL101 SC | EXPERIMENTAL | * Single fixed dose levels of AL101 administered SC * Multiple fixed dose of AL101 administered SC |
| Name | Type | Description |
|---|---|---|
| AL101 | BIOLOGICAL | Active dose of AL101 |
| Placebo | OTHER | Saline solution administered as a single and multiple infusion as placebo. |
Inclusion Criteria: * BMI 18.0-35.0 kg/m2 * 45-120 kg, inclusive * At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration o...