Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDK060 · 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 peripheral neuropathy. It is in Phase 1 clinical development and has not been approved for any indication. The current study enrolls adults aged 18 years and older with CMT1A in Canada.
EDK060 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the Phase 1 first-in-human study evaluating the compound in adults with Charcot-Marie-Tooth disease, Type 1A.
EDK060 is in Phase 1 development. It is investigational and has not been approved by the FDA or any other regulatory authority. The single ongoing trial is a first-in-human study assessing safety, tolerability, and pharmacokinetics in adults with Charcot-Marie-Tooth disease, Type 1A.
EDK060 is being studied in one active clinical trial, NCT07140614, titled a first-in-human study to assess the safety, tolerability, and pharmacokinetics of EDK060 in adults with CMT1A. The trial is currently recruiting, is placebo-controlled and double-blind, and plans to enroll 28 participants in Canada.
Yes. EDK060 is also referred to as EDK060, dose A. Both names refer to the same investigational small molecule developed by Novartis AG for Charcot-Marie-Tooth disease, Type 1A, so readers searching either term are looking at the same Phase 1 asset.
The EDK060 Phase 1 trial, NCT07140614, is a randomized, double-blind, placebo-controlled first-in-human study. It plans to enroll 28 adults aged 18 years and older with Charcot-Marie-Tooth disease, Type 1A, at sites in Canada. Participants are not healthy volunteers, and the study is currently recruiting.