A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease

Kenai Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Idiopathic Parkinson´s Disease; Parkinson's Disease

Treatments: Device: Syringe Front-Loading Device; Biological: RNDP-001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07106021

RNDP-001-02

Details and patient eligibility

About

This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.

Enrollment: 12 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria
• Age 45 to 75
• Medically stable to undergo a surgical procedure

Exclusion criteria

• Known Parkinson's disease gene mutation or variant
• Previous infusion therapy or surgery for Parkinson's disease
• History of allergic reaction or intolerance to an immunotherapeutic agent
• Contraindication to MRI
• Clinically significant medical conditions likely to interfere with the surgical procedure or study assessments

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

First patient group

Experimental group

Description:

Low dose

Treatment:

Biological: RNDP-001

Device: Syringe Front-Loading Device

Second patient group

Experimental group

Description:

High dose

Treatment:

Biological: RNDP-001

Device: Syringe Front-Loading Device

Third patient group

Experimental group

Description:

Best dose

Treatment:

Biological: RNDP-001

Device: Syringe Front-Loading Device