Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies.

@article{Muller2009SafetyAA,
  title={Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies.},
  author={Patrick Y. Muller and Frank R Brennan},
  journal={Clinical pharmacology and therapeutics},
  year={2009},
  volume={85 3},
  pages={247-58}
}
Modulating immune responses with monoclonal antibodies (mAbs) that target immune molecules has become a promising therapeutic strategy and is under investigation for the treatment of cancer and (auto)-immune diseases. A major hurdle to the development and early clinical investigation of many immunomodulatory mAbs is the inherent risk of adverse immune-mediated drug reactions in humans, such as cytokine storms, autoimmunity, and immunosuppression. Dose selection for first-in-human (FIH) clinical… CONTINUE READING