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

Last updated: January 22, 2026
Sponsor: Kenai Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

RNDP-001

Syringe Front-Loading Device

Clinical Study ID

NCT07106021
RNDP-001-02
  • Ages 45-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease consistent with the Movement DisordersSociety Clinical Criteria

  • Age 45 to 75

  • Medically stable to undergo a surgical procedure

Exclusion

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 surgicalprocedure or study assessments

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: RNDP-001
Phase: 1/2
Study Start date:
July 17, 2025
Estimated Completion Date:
June 30, 2031

Connect with a study center

  • University of Arizona

    Tucson, Arizona 85721
    United States

    Site Not Available

  • University of Arizona

    Tucson 5318313, Arizona 5551752 85721
    United States

    Active - Recruiting

  • Keck Medical Center of University of Southern California

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

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