Phase
Condition
Muscular Dystrophy
Treatment
Placebo Subcutaneous (SC) Injection
Placebo Intravenous (IV) Infusion
ARO-DM1 Intravenous (IV) Infusion
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Genetically confirmed diagnosis of DM1
Clinician-assessed signs of DM1 including clinically apparent myotonia
Onset of DM1 symptoms occurred after the age of 12 years
Walk for at least 10 meters independently at Screening
Subjects of childbearing potential must agree to use highly effective contraceptionin addition to a condom during the study and for at least 90 days following the endof study or last dose of study drug, whichever is later. Subjects must not donatesperm or eggs during the study and for at least 90 days following the end of studyor last dose of study drug whichever is later.
Exclusion
Exclusion Criteria:
Inadequately controlled diabetes
Confirmed diagnosis of congenital DM1
Uncontrolled hypertension
History of tibialis anterior (TA) biopsy within 3 months of Day 1 or planning toundergo TA biopsies during the study period
Clinically significant cardiac, liver or renal disease
HIV infection (seropositive) at Screening
Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at screening
Untreated or poorly controlled epilepsy
Treatment with anti-myotonia medication within a period of 5 half-lives of themedication prior to Screening.
Abnormal coagulation parameters at Screening including platelet count, internationalnormalized ratio (INR), prothrombin time, and activated partial thromboplastin time (APTT)
Note: Additional inclusion/exclusion criteria may apply per protocol
Study Design
Connect with a study center
Research Site
Liverpool, New South Wales 2170
AustraliaSite Not Available
Research Site
Liverpool 2159851, New South Wales 2155400 2170
AustraliaActive - Recruiting
Research Site
Birtinya, Queensland 4575
AustraliaSite Not Available
Research Site
Herston, Queensland 4029
AustraliaSite Not Available
Research Site
Birtinya 8348723, Queensland 2152274 4575
AustraliaActive - Recruiting
Research Site
Herston 6931014, Queensland 2152274 4029
AustraliaActive - Recruiting
Research Site
Melbourne, Victoria 3004
AustraliaSite Not Available
Research Site
Melbourne 2158177, Victoria 2145234 3004
AustraliaActive - Recruiting
Research Site
Christchurch, 8011
New ZealandSite Not Available
Research Site
Christchurch 2192362, 8011
New ZealandActive - Recruiting
Research Site
Taichung, 40447
TaiwanSite Not Available
Research Site
Taichung 1668399, 40447
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanActive - Recruiting
Research Site
Taipei, 10041
TaiwanSite Not Available
Research Site
Taipei 1668341, 11217
TaiwanActive - Recruiting
Research Site
Bangkok 1609350, Bangkok 1609348 10700
ThailandActive - Recruiting
Research Site
Hat Yai 1610780, Changwat Songkhla 1606146 90110
ThailandActive - Recruiting
Research Site
Hat Yai, Songkhla 90110
ThailandSite Not Available
Research Site
Bangkok, 10700
ThailandSite Not Available
Research Site
Lampang, 52000
ThailandSite Not Available
Research Site
Lampang 1152473, 52000
ThailandActive - Recruiting

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