A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease

Korábbi kezelés

• Any prior history of a severe infusion reaction.
  • Other Criteria/Social Circumstances
• Recent use of investigational drugs or therapeutic antibodies.

Más betegség

• Parkinsons's Disease Related Criteria
• History of sudden, unexpected PD medication OFF episodes.
• Any condition or health concern deemed a safety risk or likely to interfere with study results.
• Severe psychiatric disorders, including psychosis or substance addiction.
• Allergies or sensitivities to specific study-related treatments or substances.

Egyéb

• Severe motor complications or disabling symptoms that may impact study involvement.
  • Other Health Related Criteria
• Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.

• 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.