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RXRG001

Phase 1

Radiation-Induced Xerostomia and Hyposalivation | Monoclonal antibody | Other |cbdMD, Inc.|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

RXRG001 · 1 trial · 1 indication

Phase 1 1
NCT06714253Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1Radiation-Induced Xerostomia and Hyposalivation
RECRUITING42 Analytics
PHASE1RECRUITING
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Radiation-Induced Xerostomia and HyposalivationUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent serious adverse events
Part 1: up to 60 weeks, Part 2: up to 60 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RXRG001 Part 1EXPERIMENTALOpen-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)
RXRG001 Part 2EXPERIMENTALRandomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)
Placebo Part 2PLACEBO_COMPARATORRandomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)

Interventions

NameTypeDescription
RXRG001BIOLOGICALCircular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
PlaceboBIOLOGICALPlacebo (saline)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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. Bot...

Countries:United States
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