42 Participants Needed

RXRG001 for Dry Mouth

(SPRINX-1 Trial)

Recruiting at 2 trial locations
RT
Overseen ByRiboX Therapeutics Ltd.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: RiboX Therapeutics Ltd.

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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
See 1 more

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
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: RXRG001 Part 2Experimental Treatment1 Intervention
Group II: RXRG001 Part 1Experimental Treatment1 Intervention
Group III: Placebo Part 2Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

RiboX Therapeutics Ltd.

Lead Sponsor

Trials
1
Recruited
40+
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