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NCT07733349

Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Start date changed from estimate of Aug 3, 2026 to Sep 24, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Study description revised
    • Site details revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Within 6 months after administration

Secondary (5)

Changes in 18F-FP-CIT uptake detected by positron emission tomography (PET)
Changes in MDS-UPDRS scores
Changes in modified H&Y staging
Changes in daily levodopa equivalent dose (LED)
Changes in average daily 'off' and 'on' duration while awake

Arms and interventions

UX-DA003Experimental

Drugs: UX-DA003

Sites

1 site in 1 country

  • Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, China