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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02036645 | SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease. | PHASE1 | COMPLETED | 77 | — | — | Feb 4, 2014 | Sep 15, 2016 | Jun 3, 2019 | 10 | United States |
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
| Arm | Type | Description |
|---|---|---|
| MEDI1814 IV | EXPERIMENTAL | Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg. |
| IV Placebo | PLACEBO_COMPARATOR | Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg. |
| MEDI1814 Sub Cutaneous Injection | EXPERIMENTAL | 2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort |
| Subcutaneous Placebo | PLACEBO_COMPARATOR | 2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort |
| Name | Type | Description |
|---|---|---|
| MEDI1814 for IV injection | BIOLOGICAL | Monoclonal antibody for IV Injection |
| MEDI1814 for Subcutaneous Injection | BIOLOGICAL | Monoclonal antibody for subcutaneous injection |
| IV Placebo | BIOLOGICAL | Placebo for IV injection |
| Placebo for Subcutaneous Injection | BIOLOGICAL | Subcutaneous Placebo Injection |
Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease Exclusion Criteria History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically imp...