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CLINICAL TRIAL article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1474868
This article is part of the Research Topic Clinical Pharmacist Service Promotes the Improvement of Medical Quality Volume II View all 8 articles

Phase I Clinical Trial of NH130 and the Prediction of Its Pharmacokinetics Using Physiologically Based Pharmacokinetic Modeling

Provisionally accepted
Kun Zhang Kun Zhang Shanshan Zhao Shanshan Zhao *Jialin Du Jialin Du Lan Zhang Lan Zhang *
  • Xuanwu Hospital, Capital Medical University, Beijing, China

The final, formatted version of the article will be published soon.

    Background: Parkinson's disease psychosis (PDP) is a common and distressing complication of Parkinson's disease (PD), characterized by hallucinations and delusions. This research aimed to assess the pharmacokinetics and safety of NH130, a selective serotonin 5-HT2A inverse agonist, as a potential PDP treatment in healthy individuals. Methods: We conducted clinical pharmacokinetic studies and safety evaluations for NH130, employing a physiologically based pharmacokinetic (PBPK) model to predict its behavior in human body. Results: In a single-dose escalation study, healthy volunteers received NH130 at varying doses (2 mg, 6 mg, 12 mg, 24 mg, 40 mg, 60 mg, and 90 mg) or a placebo. The drug demonstrated favorable pharmacokinetics, with no serious adverse events (AEs) reported. Clinical plasma concentrations correlated well with PBPK model predictions, validating the model's utility for guiding future clinical development.Conclusion: NH130 showed promising pharmacokinetic characteristics and safety profile, supporting its progression to multi-dose trials and suggesting its potential as a therapeutic agent for PDP.

    Keywords: Parkinson's disease, psychosis, pharmacokinetics, physiologically based pharmacokinetic model, PBPK, first-in-human

    Received: 02 Aug 2024; Accepted: 30 Aug 2024.

    Copyright: © 2024 Zhang, Zhao, Du and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Shanshan Zhao, Xuanwu Hospital, Capital Medical University, Beijing, China
    Lan Zhang, Xuanwu Hospital, Capital Medical University, Beijing, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.