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NCT05230459 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects With Genetic Confirmation of LGMD2I/R9 (Part1)
A Phase 1 study of Muscular Dystrophy and Limb Girdle Muscular Dystrophy, sponsored by AskBio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 6
- Study locations
NCT05230459 is a Phase 1 study of Muscular Dystrophy and Limb Girdle Muscular Dystrophy that is actively recruiting participants, run by AskBio. The registered enrollment target is 10 participants, below the 880-participant average among 11 other Muscular Dystrophy trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT05230459, a Phase 1 study of Muscular Dystrophy and Limb Girdle Muscular Dystrophy, is actively recruiting participants, sponsored by AskBio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Participants will be treated in sequential, dose-level cohorts. (Part 1)
Conditions Studied
Interventions
- OTHER Placebo
- GENETIC AB-1003 dose level 1
- GENETIC AB-1003 dose level 2
Study Locations (6)
California
- University of California - Irvine - Irvine
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Maryland
- Kennedy Krieger Institute - Baltimore
Virginia
- VCU - Richmond
Washington
- University of Washington Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2032-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05230459
The ClinicalTrials.gov registry entry for NCT05230459 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 880-participant average among 11 other Muscular Dystrophy trials with a reported enrollment target (99% lower). The listed sponsor is AskBio, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Muscular Dystrophy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05230459 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Iowa, Kansas.
Frequently Asked Questions
What is clinical trial NCT05230459 about?
NCT05230459 is a clinical study titled "A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects With Genetic Confirmation of LGMD2I/R9 (Part1)". The purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Participants will be treated in sequential, dose-level cohorts. (Part 1)
What is the current status of trial NCT05230459?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-05-15. Estimated completion is 2032-12.
What conditions does trial NCT05230459 study?
This clinical trial studies the following conditions: Muscular Dystrophy, Limb Girdle Muscular Dystrophy, LGMD2I, Limb-Girdle Muscular Dystrophy Type 2, LGMD2.
What interventions are being tested in trial NCT05230459?
The interventions under investigation include: Placebo (OTHER), AB-1003 dose level 1 (GENETIC), AB-1003 dose level 2 (GENETIC).
Who is sponsoring clinical trial NCT05230459?
This trial is sponsored by AskBio, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05230459 being conducted?
This trial has 6 study locations across California, Iowa, Kansas, Maryland, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.