Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDK060, dose A · 1 trial · 1 indication
Incidence of AEs and SAEs by treatment group, including changes in vital signs, laboratory measures, neurological examinations and electrophysiology measures qualifying and reported as AEs.
| Arm | Type | Description |
|---|---|---|
| EDK060 | EXPERIMENTAL | Doses A; B; C; D |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| EDK060, dose A | DRUG | EDK060, dose A, Single dose, IV infusion |
| EDK060, dose B | DRUG | EDK060, dose B, Single dose, IV infusion |
| EDK060, dose C | DRUG | EDK060, dose C, Single dose, IV infusion |
| EDK060, dose D | DRUG | EDK060, dose D, Single dose, IV infusion |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Provide written informed consent before any assessment is performed. * Be male or female and 18 to 60 (inclusive) years of age at the time of screening. * Participant must have a clinical diagnosis of Charcot-Marie-Tooth Disease Type 1A (CMT1A) including verified documentation...
EDK060 is an investigational small molecule being developed for Charcot-Marie-Tooth Disease, Type 1A (CMT1A), a rare inherited neurological disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
EDK060 is being developed by Novartis AG (NVS), a global pharmaceutical company. The drug is currently in Phase 1 clinical trials for Charcot-Marie-Tooth Disease, Type 1A.
EDK060 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. A first-in-human study is currently recruiting participants.
EDK060 is being studied in a Phase 1 clinical trial with the identifier NCT07140614. This first-in-human study assesses the safety, tolerability, and pharmacokinetics of EDK060 in adults with Charcot-Marie-Tooth Disease, Type 1A. The trial is recruiting 28 participants in Canada.
The drug is referred to as EDK060, dose A in the clinical trial context. This designation indicates a specific dose level being evaluated in the Phase 1 study. The drug is not known by any other alternative names.