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COMPLETED
NCT05479981
PHASE2

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

Sponsor: Avidity Biosciences, Inc.

View on ClinicalTrials.gov

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

Official title: A Phase 2 Extension Study to Evaluate the Long-Term Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) Patients

Key Details

Gender

All

Age Range

18 Years - 66 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2022-08-04

Completion Date

2025-09-10

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

Placebo

Placebo will be administered by intravenous (IV) infusion.

DRUG

AOC 1001

AOC 1001 will be administered by intravenous (IV) infusion.

Locations (8)

University of California Los Angeles

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

University of Colorado

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Rochester Medical Center

Rochester, New York, United States

Ohio State University

Columbus, Ohio, United States

Virginia Commonwealth University

Richmond, Virginia, United States