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

Phase 1

Recruiting

• Conditions: Radiation-Induced Xerostomia and Hyposalivation
• Interventions: Biological: RXRG001; Biological: Placebo

• Registration Number: NCT06714253
• Lead Sponsor: RiboX Therapeutics Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Status Verified: 2025-03
• Study Start: 2025-03-05
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RXRG001 Part 1	RXRG001	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)
RXRG001 Part 2	RXRG001	Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)
Placebo Part 2	Placebo	Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	Part 1: up to 36 weeks, Part 2: up to 36 weeks	Incidence of treatment-emergent adverse events
Incidence of treatment-emergent serious adverse events	Part 1: up to 36 weeks, Part 2: up to 36 weeks	Incidence of treatment-emergent serious adverse events

Trial Locations

Locations (3)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

John Hopkins University, Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman; 🇺🇸 Philadelphia, Pennsylvania, United States