Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease

Recruiting Phase 1 Phase 2 Interventional Study
Parkinson Disease (PD)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Industry
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About This Trial
This study is a Phase I/II clinical study to evaluate the safety, tolerability, and efficacy of XS411 in the treatment of EOPD. The study consists of two phases: Phase I and Phase II. Phase I study is planned to be conducted in patients with EOPD, using a single-arm, open-label, traditional " 3+3 " dose-escalation design, aiming to investigate the safety, tolerability and preliminary efficacy of …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 18 years old ≤ age of onset ≤ 50 years old, diagnosed with EOPD (meeting the MDS 2015 clinical diagnostic criteria for Parkinson's disease ); * 18 years old ≤ age at enrollment ≤ 70 years old , male/female; * Disease duration ≥ 5 years; * Phase I: the modified Hoehn-Yahr grade…
Contacts

Michael LEE

+86 21 64027719

CEO@xellsmart.com

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