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โ† Trials
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A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1

RecruitingPhase 2Ages 16 Years - 65 YearsAllPepGen Inc
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to learn about the effects of an investigational medicine, PGN-EDODM1, to see how safe and tolerable multiple administrations of PGN-EDODM1 are for people with myotonic dystrophy type 1 (DM1) compared to placebo.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Confirmed diagnosis of DM1, as defined as having a repeat sequence in the DMPK gene with at least 100 CTG repeats * Presence of myotonia * Have sufficient muscle mass in bilateral tibialis anterior (TA) muscles that a needle biopsy can safely be performed * Body Mass Index (BMI) of \< 35.0 kg/m\^2 Exclusion Criteria: * Congenital DM1 * Known history or presence of any clinically significant conditions that may interfere with study safety assessments * Abnormal laboratory tests at screening considered clinically significant by the Investigator * Medications specific for the treatment of myotonia within 2 weeks prior to screening * Percent predicted forced vital capacity (FVC) \<40% * Use of an investigational drug, device, or product within 30 days of 5 half-lives of the study drug (whichever is longer) prior to Screening Note: Other inclusion and exclusion criteria may apply.
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What it tests

  • PGN-EDODM1
  • Placebo
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Where

12 sites
University of Calgary
Calgary, Canada
Ottawa Hospital Research Institute (OHRI)
Ottawa, Canada
CIUSSS du Saguenay-Lac-Saint-Jean
Chicoutimi, Canada
Montreal Neurological Institute
Montreal, Canada
Pacific Clinical Research Network Auckland
Takapuna, New Zealand
Pusan National University Yangsan Hospital
Pusan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Seoul National University Hospital
Seoul, South Korea

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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