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.
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