RecruitingPhase 1NCT07140614

A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of EDK060 in Adults With CMT1A.

A First-in-human, Multi-center, Randomized, Participant- and Investigator-blinded, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EDK060 in Adults With Charcot-Marie Tooth Type 1A (CMT1A).

Sponsor

Novartis Pharmaceuticals

Enrollment

28 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Charcot-Marie-Tooth Disease, Type 1A

Summary

The purpose of this study is to characterize the safety, tolerability, and pharmacokinetics of EDK060 as compared to placebo in adult patients with CMT1A.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called EDK060, dose A, a drug called EDK060, dose B, and others for people with charcot-marie-tooth disease, type 1a. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEDK060, dose A

EDK060, dose A, Single dose, IV infusion

DRUGEDK060, dose B

EDK060, dose B, Single dose, IV infusion

DRUGEDK060, dose C

EDK060, dose C, Single dose, IV infusion

DRUGEDK060, dose D

EDK060, dose D, Single dose, IV infusion

OTHERPlacebo

Placebo

Locations(3)

The Ottawa Hospital

Ottawa, Ontario, Canada

Montreal Neurological Institute

Montreal, Quebec, Canada

CIUSS de l´Estrie-CHUS- Hôpital Fleurimont

Sherbrooke, Quebec, Canada

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NCT07140614

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