NCT06714253 Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
| NCT ID | NCT06714253 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | RiboX Therapeutics Ltd. |
| Condition | Radiation-Induced Xerostomia and Hyposalivation |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-03-05 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2025-03-05 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria\* 1. At least 18 years of age 2. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years 3. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months 4. Both parotid glands on imaging examination Exclusion Criteria\* 1. Any active infection 2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c \>=8%) 3. History of autoimmune diseases known to potentially affect the salivary glands 4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers 5. Active smoker or use tobacco products or have a history of substance or alcohol abuse * Other criteria apply
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06714253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation-Induced Xerostomia and Hyposalivation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06714253 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06714253 currently recruiting?
Yes, NCT06714253 is actively recruiting participants. Contact the research team at RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com for enrollment information.
Where is the NCT06714253 trial being conducted?
This trial is being conducted at Palo Alto, United States, Iowa City, United States, Baltimore, United States, New York, United States and 1 additional location.
Who is sponsoring the NCT06714253 clinical trial?
NCT06714253 is sponsored by RiboX Therapeutics Ltd.. The trial plans to enroll 42 participants.