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NCT06714253 · ClinicalTrials.gov registry record · Phase 1
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
A Phase 1 study of Radiation-Induced Xerostomia and Hyposalivation, sponsored by RiboX Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 4
- Study locations
NCT06714253: Recruiting Phase 1 study of Radiation-Induced Xerostomia and Hyposalivation, sponsored by RiboX Therapeutics.
NCT06714253 is a Phase 1 study of Radiation-Induced Xerostomia and Hyposalivation that is actively recruiting participants, run by RiboX Therapeutics. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06714253, a Phase 1 study of Radiation-Induced Xerostomia and Hyposalivation, is actively recruiting participants, sponsored by RiboX Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production). In Part 1 of the study (open-label, single-arm), patients will receive unilateral administrations of RXRG001 in 3 single ascending dose cohorts and in 3 multiple ascending dose cohorts. Part 2 of the study has a randomized, double-blind, placebo-controlled design. Patients will receive bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts.
Primary Outcome
Incidence of treatment-emergent adverse events
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RXRG001
Study Locations (4)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Maryland
- John Hopkins University, Sidney Kimmel Comprehensive Cancer Center - Baltimore
New York
- NYU Langone Medical Center - New York
Pennsylvania
- Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2025-03-05 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
What NCT06714253 shows while recruiting
NCT06714253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Radiation-Induced Xerostomia and Hyposalivation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06714253 reports a single indexed study location in Iowa, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT06714253 about?
NCT06714253 is a clinical study titled "Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1". This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production). In Part 1 of the study (open-label, si...
What is the current status of trial NCT06714253?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2025-03-05. Estimated completion is 2027-08.
What conditions does trial NCT06714253 study?
This clinical trial studies the following conditions: Radiation-Induced Xerostomia and Hyposalivation.
What interventions are being tested in trial NCT06714253?
The interventions under investigation include: Placebo (BIOLOGICAL), RXRG001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06714253?
This trial is sponsored by RiboX Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06714253 being conducted?
This trial has 4 study locations across Iowa, Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06714253's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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
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