NH130, a selective serotonin 5-HT2A inverse agonist, has shown promising results in a Phase I clinical trial for the potential treatment of Parkinson's disease psychosis (PDP). The study, published in Frontiers in Pharmacology, assessed the pharmacokinetics and safety of NH130 in healthy individuals, utilizing a physiologically based pharmacokinetic (PBPK) model to predict its behavior in the human body.
The single-dose escalation study involved healthy volunteers who received NH130 at doses ranging from 2 mg to 90 mg, or a placebo. The results indicated that NH130 exhibited favorable pharmacokinetics, with no serious adverse events (AEs) reported. Furthermore, clinical plasma concentrations correlated well with the PBPK model predictions, validating the model's utility for guiding future clinical development.
Parkinson's disease psychosis (PDP) is a common and distressing complication of Parkinson's disease (PD), characterized by hallucinations and delusions. Current treatments have limitations, highlighting the need for new therapeutic options. This Phase I trial provides initial evidence supporting the potential of NH130 as a therapeutic agent for PDP.
The study's findings suggest that NH130 is well-tolerated and exhibits predictable pharmacokinetic behavior. The successful application of the PBPK model further enhances the understanding of NH130's behavior in the body and can inform future dosing strategies. These results warrant further investigation in multi-dose trials to evaluate the efficacy of NH130 in patients with PDP.
Trial Design and Methodology
The Phase I clinical trial was designed as a single-dose escalation study. Healthy volunteers were administered single doses of NH130 (2 mg, 6 mg, 12 mg, 24 mg, 40 mg, 60 mg, and 90 mg) or a placebo. Plasma concentrations of NH130 were measured at various time points to assess its pharmacokinetic properties. The PBPK model was developed and validated using the clinical data to predict NH130's pharmacokinetic behavior. Safety assessments were conducted throughout the study to monitor for any adverse events.
Implications for Future Research
The positive outcomes of this Phase I trial pave the way for future multi-dose studies to evaluate the efficacy and long-term safety of NH130 in patients with Parkinson's disease psychosis. Further research is needed to determine the optimal dosing regimen and to assess the clinical benefits of NH130 in this patient population.
