NCT07733349RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Phase I/II Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 23 Jul 2026
- Start date
- 24 Sept 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Shanghai UniXell Biotechnology Co., Ltd
- Diseases
- Parkinson disease
- NCT number
- NCT07733349
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From 24 Sept 2026 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them
Other illness
- 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
- 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
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.