A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease
The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).
• Participants voluntarily agree to participate in this study and sign an Institutional Review Board (IRB)-approved informed consent form (ICF) prior to performing any of the screening procedures.
• Parkinson's Disease Related Criteria:
• Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
• Less than 5 years from the initial PD diagnosis, at the time of ICF.
• Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
• Participants who are on immediate-release levodopa-carbidopa/benserazide.
• Other Health Related Criteria
• No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
• Free of significant health issues that might interfere with study participation.
• Other Criteria/Social Circumstances
• Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.