CompletedPhase 2

Extension of AOC 1001-CS1 (MARINA) Study in Adult Myotonic Dystrophy Type 1 (DM1) Patients

United States37 participantsStarted 2022-08-04

Plain-language summary

AOC 1001-CS2 (MARINA-OLE) is a Phase 2 extension of the AOC 1001-CS1 (MARINA) study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple-doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) patients

Who can participate

Age range18 Years – 66 Years

SexALL

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Key Inclusion Criteria: * Completion of AOC 1001-CS1 (MARINA) study with satisfactory compliance and no significant tolerability issues Key Exclusion Criteria: * Pregnancy, intent to become pregnant, or active breastfeeding * Unwilling or unable to continue to comply with contraceptive requirements * Any new conditions or worsening of existing conditions that in the opinion of the investigator or sponsor would make the participant unsuitable for the study or could interfere with participation or completion of the study

What they're measuring

Number and severity of treatment-emergent adverse events (TEAEs)

Timeframe: Through study completion

Trial details

NCT IDNCT05479981

SponsorAvidity Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-05

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