Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Oculopharyngeal Muscular Dystrophy, sponsored by Benitec Biopharma.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A DLT will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as follows: • Any Grade 2 toxicity not resolving within 14 days or any Grade 3 toxicity, assessed to be possibly related to the investigational product.
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 |
What NCT06185673 shows while recruiting
NCT06185673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06185673's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI