Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Purpose
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.
Condition
- Radiation-Induced Xerostomia and Hyposalivation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Part 1 (Phase 1): single-arm, open-label Part 2 (Phase 2): randomized, double-blind, placebo-controlled, parallel-group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Part 1 (Phase 1): single-arm open-label Part 2 (Phase2): randomized, double-blind, placebo-controlled, parallel-group
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RXRG001 Part 1 |
Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral) |
|
|
Experimental RXRG001 Part 2 |
Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral) |
|
|
Placebo Comparator Placebo Part 2 |
Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral) |
|
Recruiting Locations
Iowa City, Iowa 52242
Principal Investigator
Baltimore, Maryland 21287
Principal Investigator
New York, New York 10016-6402
Principal Investigator
Philadelphia, Pennsylvania 19104
Principal Investigator
More Details
- NCT ID
- NCT06714253
- Status
- Recruiting
- Sponsor
- RiboX Therapeutics Ltd.
Study Contact
RiboX Therapeutics Ltd.609 212 2832
RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com