Category: Parkinson’s Disease: Clinical Trials
Objective: To describe the study design of a Phase 1b to test the safety, pharmacokinetics, and pharmacodynamics of a novel inflammasome inhibitor in individuals with early-stage Parkinson’s disease (PD).
Background: Preclinical studies showed that inflammasome activation may be a key driver of PD progression but, to date, there are no studies investigating inflammasome inhibitors in early-stage PD.
Method: Individuals with early-stage PD (treatment-naive or on stable symptomatic therapy) will be recruited in this Phase 1b study to test the safety, pharmacokinetics, and pharmacodynamics of a novel compound acting on neuroinflammation in early-stage PD.
Results: The study design will be described, including inclusion/exclusion criteria, safety, pharmacokinetics, and pharmacodynamic parameters selected for this Phase 1b study.
Conclusion: To characterize a novel compound acting on the inflammasome, an innovative Phase 1b study design is needed to investigate safety, pharmacokinetics, and pharmacodynamics.
To cite this abstract in AMA style:
G. D'Urso, A. Thomann, J. Anzures-Cabrera, B. Zinnhardt, B. Ricci, M. Marchesi, V. Machado, E. Mracsko, N. Pavese, K. Marek, K. Brockmann, T. Simuni, N. Milani Muelhardt, G. Pagano. A Phase 1b study to test the safety, pharmacokinetics, and pharmacodynamics of a novel inflammasome inhibitor in early-stage Parkinson’s disease: Rationale and study design [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/a-phase-1b-study-to-test-the-safety-pharmacokinetics-and-pharmacodynamics-of-a-novel-inflammasome-inhibitor-in-early-stage-parkinsons-disease-rationale-and-study-design/. Accessed June 14, 2025.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-phase-1b-study-to-test-the-safety-pharmacokinetics-and-pharmacodynamics-of-a-novel-inflammasome-inhibitor-in-early-stage-parkinsons-disease-rationale-and-study-design/