Category: Parkinson’s Disease: Clinical Trials
Objective: To evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ABBV-0805 following administration of single ascending doses of ABBV-0805, administered as intravenous (IV) infusions in healthy subjects.
Background: Parkinson’s disease (PD) is the most common movement disorder and the second most common neurodegenerative disease. Current pharmacological treatments for PD focus on symptom management and most commonly target the dopaminergic pathway. Pathological and genetic evidence implicates toxic effects of aggregated α-synuclein as compared to monomeric α-synuclein in the pathophysiology of PD. Development of monoclonal antibodies (mAbs) targeting soluble oligomeric α-synuclein is a promising strategy for delaying disease progression. ABBV-0805 is an IgG4 mAb that selectively targets human oligomeric α-synuclein. It is currently being developed as a novel disease-modifying treatment for PD by AbbVie.
Method: Healthy volunteers between 30-65 years of age were enrolled in a first-in-human (FIH) Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of single ascending doses of ABBV-0805. Single IV doses of ABBV-0805 have been administered to 44 healthy volunteers across 5 cohorts with 2 subjects receiving placebo and 6 subjects receiving ABBV-0805 infusions in each cohort. Vital signs, ECGs and AEs were recorded, and PK, anti-drug-antibody and biomarker samples were obtained throughout the study.
Results: Single ABBV-0805 IV infusions administered to healthy volunteers in FIH study have been well-tolerated, with no concerning safety findings related to adverse events, laboratory results, vital signs, or ECGs. Preliminary data suggests a favorable PK, pharmacodynamic and immunogenicity profile for ABBV-0805.
Conclusion: Preliminary human exposure, biomarker and safety data being gathered in an ongoing Phase 1 FIH study supports Phase 2 development of ABBV-0805.
To cite this abstract in AMA style:H. Kalluri, C. Zadikoff, L. Rueter, O. Graff, H. Xiong. Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-0805, an Anti-Alpha-Synuclein Monoclonal Antibody in Healthy Subjects [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/randomized-placebo-controlled-single-ascending-dose-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-abbv-0805-an-anti-alpha-synuclein-monoclonal-antibody-in-healt/. Accessed December 7, 2023.
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