NCT07733349 Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
| NCT ID | NCT07733349 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai UniXell Biotechnology Co., Ltd |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-09-24 |
| Primary Completion | 2029-08-31 |
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 2026-09-24 with a primary completion date of 2029-08-31.
⚠ 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 study is designed to explore the safety and tolerability of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.
Eligibility Criteria
Inclusion Criteria: * Aged between 30 and 75 years, regardless of gender * Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years * Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the efficacy has significantly declined * Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30% * The modified H\&Y staging (Off period) of ≥2.5 and ≤4, with total daily "off" time \>2 hours * Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening * Good physical condition or stable concomitant diseases Exclusion Criteria: * The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome * Severe systemic diseases or functional impairments * Evidence of active infection or chronic infection, which may pose a risk to the subject * Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders * Subjects with a history of brain injuries, cerebral vascular malformations, hydrocephalus, brain tumors, or other brain damages as shown by previous Head CT/MRI scans, or subjects with abnormal brain imaging in the striatum or other brain regions that significantly increase surgical risks * Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other interventional clinical trials within the last 3 months * Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them * Pregnant or breastfeeding women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07733349 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying 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 NCT07733349 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 NCT07733349 currently recruiting?
Yes, NCT07733349 is actively recruiting participants. Contact the research team at jly0520@hotmail.com for enrollment information.
Where is the NCT07733349 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07733349 clinical trial?
NCT07733349 is sponsored by Shanghai UniXell Biotechnology Co., Ltd. The trial plans to enroll 12 participants.
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