RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing UX-DA003 for Parkinson's Disease

This clinical study is designed to explore the whether it is safe and how hard side effects are to live with of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.

Official registry: https://clinicaltrials.gov/study/NCT07733349 · Shanghai UniXell Biotechnology Co., Ltd · enrollment listed as 12

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are UX-DA003. The registry lists allocation as na. This clinical study is designed to explore the whether it is safe and how hard side effects are to live with of UX-DA003.

They plan to enroll about 12 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase I/II Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection in Patients With Parkinson's Disease

Interventions: UX-DA003

Primary outcome (registry wording): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Who it is for (from inclusion criteria)

Ages 30 Years to 75 Years
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 how well it works 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

Who the registry excludes

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 who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other treatment 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

Public study contact (from the registry)

Jun Liu, MD, PhD

+86-21-64370045

jly0520@hotmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (recruiting)

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FAQ about this NCT record

Is NCT07733349 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07733349?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07733349?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary