Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1

Conditions

• Radiation-Induced Xerostomia and Hyposalivation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RXRG001 — BIOLOGICAL
  Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
• Placebo — BIOLOGICAL
  Placebo (saline)

Study Details

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.

Key Dates

Start date

Mar 5, 2025

Status verified

May 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

42 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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)

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks ]

Central Contacts

• RiboX Therapeutics Ltd.
  617-999-8257
  [email protected]

Locations (4)

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