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Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients

Study acronym: MARINA
StatusCompleted
PhasePhase 1/2
Started
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Record History

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  1. Results posted: Sep 28, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (8)
    • Publications: details revised at 1 of 1 entry
  2. Secondary endpoints revised (8)v10
  3. Secondary endpoints revised (8)
    • Primary endpoint revised
    v9
  4. Enrollment target: 38 to 39v8
  5. Re-verified, no change to tracked fieldsv7
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  1. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 44 to confirmed 38
    • Primary and study completion dates changed from estimate of Sep 2023 to Feb 14, 2023
    v6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 8 of 8 sites
    v5
  3. Site details revised at 1 of 8 sitesv4
  4. Site details revised at 2 of 8 sitesv3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 8
    • Start date changed from estimate of Oct 2021 to Oct 28, 2021
    • Eligibility criteria expanded, about 10 words
    • Study title shortened, about 11 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AOC 1001-CS1 is a randomized, double-blind, placebo-controlled, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple-doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) patients (MARINA). Part A is a single dose design with 1 cohort (dose level). In Part A, the patient duration is 6 months as the treatment period is 1 day followed by a 6 month follow-up period. Part B is a multiple-ascending dose design with 2 cohorts (dose levels). In Part B, the patient duration is 6 months as the treatment period is 3 months followed by a 3 month follow-up period.
Trial Details
NCT Number NCT05027269
Lead Sponsor Avidity Biosciences, Inc.
Conditions
(from sponsor)		 DM1, Myotonic Dystrophy 1, Myotonic Dystrophy, Myotonic Dystrophy Type 1 (DM1), Dystrophy Myotonic, Myotonic Disorders, Steinert Disease, Myotonic Muscular Dystrophy
Related terms Myotonic Disorders, Myotonic Dystrophy
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov