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Study identifier: NCT06300307 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study of ATX-01 in Participants With DM1

Condition: Myotonic Dystrophy 1  ·  Sponsor: ARTHEx Biotech S.L.

PhasePhase 1/Phase 2
Planned participants56
Who can joinAll sexes, 18 Years to 64 Years
Healthy volunteersNo

About this study

The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo. There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo. ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b.

This description comes directly from the study's public registry record.

Talk to the study team

Project Manager  ·  +34676229821  ·  clinical@arthexbiotech.com

Always discuss trial participation with your own doctor first.

Locations (12)

UCLALos Angeles, California, United StatesRecruiting
University of FloridaGainesville, Florida, United StatesRecruiting
University of Iowa Health Care - Department of NeurologyIowa City, Iowa, United StatesRecruiting
University of Kansas Medical Center, Department of NeurologyFairway, Kansas, United StatesRecruiting
Virginia Commonwealth UniversityRichmond, Virginia, United StatesRecruiting
Centre Intégré Universitaire de Santé et Services Sociaux du Saguenay-Lac-St-JeanChicoutimi, Quebec, CanadaRecruiting
Institute of MyologyParis, FranceRecruiting
The NeMO Clinical Center in Milan, Neurorehabilitation Unit, University of MilanMilan, ItalyRecruiting
Fondazione Policlinico A. Gemelli- IRCCSRome, ItalyRecruiting
RadboudumcNijmegen, NetherlandsRecruiting
Hospital Universitario DonostiaDonostia / San Sebastian, SpainRecruiting
St. George's University HospitalLondon, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06300307