Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PMN310 · 2 trials · 2 indications
Number and severity of adverse events
Mean change in plasma p-tau217 in response to repeat intravenous infusions of PMN310
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 PMN310 350 mg or placebo | EXPERIMENTAL | PMN310 350 mg or placebo administered as a 60-minute infusion. |
| Cohort 2 PMN310 700 mg or placebo | EXPERIMENTAL | PMN310 700 mg or placebo administered as a 60-minute infusion. |
| Cohort 3 PMN310 1400 mg or placebo | EXPERIMENTAL | PMN310 1400 mg or placebo administered as a 60-minute infusion. |
| Cohort 1 PMN310 175mg or placebo | EXPERIMENTAL | PMN310 175mg or placebo administered as a 60-minute infusion. |
| Cohort 2 PMN310 350mg or placebo | EXPERIMENTAL | PMN310 350mg or placebo administered as a 60-minute infusion. |
| Cohort 3 PMN310 700mg or placebo | EXPERIMENTAL | PMN310 700mg or placebo administered as a 60-minute infusion. |
| Cohort 4 PMN310 1400mg or placebo | EXPERIMENTAL | PMN310 1400mg or placebo administered as a 60-minute infusion. |
| Cohort 5 PMN310 2800mg or placebo | EXPERIMENTAL | PMN310 2800mg or placebo administered as a 60-minute infusion. |
| Name | Type | Description |
|---|---|---|
| PMN310 | DRUG | A humanized immunoglobulin G1 (IgG1) monoclonal antibody |
| Placebo | DRUG | 0.9% NaCl 100 mL |
Inclusion Criteria: 1. Patient and caregiver provide written informed consent. 2. Ambulatory male or female ≥ 50 years of age with adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the Investigator. 3. Meets all of the following clinical cr...