RXRG001 for Dry Mouth

(SPRINX-1 Trial)

Recruiting at 2 trial locations

Overseen By RiboX Therapeutics Ltd.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: RiboX Therapeutics Ltd.

Disqualifiers: Infection, Heart failure, Diabetes, Autoimmune, others

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for adults with dry mouth caused by radiation therapy, specifically those who produce less saliva. Participants must be healthy enough to undergo the treatment and not have conditions that could interfere with the study or pose additional health risks.

Inclusion Criteria

I have had dry mouth or low saliva for over 3 months after treatment.

I have been cancer-free and had no other cancer types for at least 2 years.

Both parotid glands on imaging examination

Exclusion Criteria

I do not have heart failure, kidney issues, or uncontrolled diabetes (A1c <= 8%).

I do not have any active infections.

Active smoker or use tobacco products or have a history of substance or alcohol abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Open-label, single-arm study with unilateral administrations of RXRG001 in 3 single ascending dose cohorts and 3 multiple ascending dose cohorts

36 weeks

Treatment Part 2

Randomized, double-blind, placebo-controlled study with bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• RXRG001

Trial Overview The study tests RXRG001, a new circular RNA treatment administered into salivary glands. It has two parts: an initial phase where patients get varying doses in one gland, and a second double-blind phase where they receive it in both glands or a placebo without knowing which.

Participant Groups

Group I: RXRG001 Part 2 Experimental Treatment 1 Intervention

Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)

Group II: RXRG001 Part 1 Experimental Treatment 1 Intervention

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)

Group III: Placebo Part 2 Placebo Group 1 Intervention

Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)

Who Is Running the Clinical Trial?

RiboX Therapeutics Ltd.

Lead Sponsor

Trials

1

Recruited

40+