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

NCT07140614 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Charcot-Marie-Tooth Disease, Type 1A

Interventions

DRUG

EDK060, dose A

EDK060, dose A, Single dose, IV infusion

DRUG

EDK060, dose B

EDK060, dose B, Single dose, IV infusion

DRUG

EDK060, dose C

EDK060, dose C, Single dose, IV infusion

DRUG

EDK060, dose D

EDK060, dose D, Single dose, IV infusion

OTHER

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-02-25
Completion
2028-02-26
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140614 on ClinicalTrials.gov