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NCT06185673 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Clinical Activity of Intramuscular Doses of BB-301 Administered to Subjects With Oculopharyngeal Muscular Dystrophy With Dysphagia
A Phase 1 study of Oculopharyngeal Muscular Dystrophy, sponsored by Benitec Biopharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06185673 is a Phase 1 study of Oculopharyngeal Muscular Dystrophy that is actively recruiting participants, run by Benitec Biopharma. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06185673, a Phase 1 study of Oculopharyngeal Muscular Dystrophy, is actively recruiting participants, sponsored by Benitec Biopharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Subjects who have enrolled in the oculopharyngeal muscular dystrophy (OPMD) natural history study (Study BNTC-OPMD-NH-001) and have completed at least 6 months of follow up in Study BNTC-OPMD-NH-001 may be eligible to participate in this study, where all subjects will be treated with a single dose of BB-301. BB-301 will be injected directly into the middle pharyngeal constrictor muscle and the inferior pharyngeal constrictor muscle of the throat through the use of an open surgical procedure conducted under general anesthesia. The primary objectives of the study are to evaluate the safety of BB-301, to identify the best dose of BB-301 to administer to patients, and to characterize how well BB-301 works to improve the symptoms of dysphagia in patients with OPMD.
Conditions Studied
Interventions
- GENETIC BB-301: Dose escalation phase 1b cohort 1
- GENETIC BB-301: Dose escalation phase 1b cohort 2
- GENETIC BB-301: Dose escalation phase 1b cohort 3
- GENETIC BB-301: Dose expansion phase 2a
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-11-28 |
| Est. Completion | 2040-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06185673
The ClinicalTrials.gov registry entry for NCT06185673 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Benitec Biopharma, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Oculopharyngeal Muscular Dystrophy appearing as the primary indexed condition, and to 4 interventions - of which BB-301: Dose escalation phase 1b cohort 1 is the first listed.
NCT06185673 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06185673 about?
NCT06185673 is a clinical study titled "A Study to Evaluate the Safety and Clinical Activity of Intramuscular Doses of BB-301 Administered to Subjects With Oculopharyngeal Muscular Dystrophy With Dysphagia". Subjects who have enrolled in the oculopharyngeal muscular dystrophy (OPMD) natural history study (Study BNTC-OPMD-NH-001) and have completed at least 6 months of follow up in Study BNTC-OPMD-NH-001 may be eligible to participate in this study, where all subjects will be treated with a single dose o...
What is the current status of trial NCT06185673?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-11-28. Estimated completion is 2040-11.
What conditions does trial NCT06185673 study?
This clinical trial studies the following conditions: Oculopharyngeal Muscular Dystrophy.
What interventions are being tested in trial NCT06185673?
The interventions under investigation include: BB-301: Dose escalation phase 1b cohort 1 (GENETIC), BB-301: Dose escalation phase 1b cohort 2 (GENETIC), BB-301: Dose escalation phase 1b cohort 3 (GENETIC), BB-301: Dose expansion phase 2a (GENETIC).
Who is sponsoring clinical trial NCT06185673?
This trial is sponsored by Benitec Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06185673 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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