NCT07106021 A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
| NCT ID | NCT07106021 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Kenai Therapeutics |
| Condition | Idiopathic Parkinson´s Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-07-17 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07106021 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Idiopathic Parkinson´s Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07106021 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07106021 currently recruiting?
Yes, NCT07106021 is actively recruiting participants. Contact the research team at patients@kenaitx.com for enrollment information.
Where is the NCT07106021 trial being conducted?
This trial is being conducted at Tucson, United States, Los Angeles, United States, Columbus, United States.
Who is sponsoring the NCT07106021 clinical trial?
NCT07106021 is sponsored by Kenai Therapeutics. The trial plans to enroll 12 participants.
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