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NCT05027269 · ClinicalTrials.gov registry record · Phase 1
Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients
A Phase 1 study, sponsored by Avidity Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT05027269 is a Phase 1 study that has completed, run by Avidity Biosciences. The registered enrollment target is 39 participants.
The verdict
NCT05027269, a Phase 1 study, has completed, sponsored by Avidity Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG AOC 1001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2023-02-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05027269
The ClinicalTrials.gov registry entry for NCT05027269 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avidity Biosciences, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05027269 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05027269 about?
NCT05027269 is a clinical study titled "Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients". 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 sin...
What is the current status of trial NCT05027269?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2021-10-28. Estimated completion is 2023-02-14.
What interventions are being tested in trial NCT05027269?
The interventions under investigation include: Placebo (DRUG), AOC 1001 (DRUG).
Who is sponsoring clinical trial NCT05027269?
This trial is sponsored by Avidity Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
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