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This project centers on advancing ImmunoThera BioTech’s lead immunotherapy candidate, ImmunoThera-2, through the critical phase of First-in-Human (FIH) clinical studies. MAQTOX is collaborating with ImmunoThera BioTech to design, implement, and manage FIH trials to evaluate the safety, pharmacokinetics, and efficacy of ImmunoThera-2 in human subjects. The goal is to establish its potential as a treatment for various autoimmune disorders, paving the way for further clinical development.

Key components of the project include:
  • Structuring Phase I clinical trials, focusing on optimal dosing and safety assessments.
  • Working closely with regulatory authorities to ensure compliance for the submission of IND (Investigational New Drug) applications.
  • Monitoring for any adverse effects and conducting long-term safety studies.
  • Performing detailed pharmacokinetic analysis to inform future trial phases.

This project represents a crucial step toward bringing ImmunoThera-2 to market, with the potential to revolutionize the treatment of autoimmune diseases and offer novel therapeutic options for patients.

  • Client
    ImmunoThera BioTech
  • Budget
    $8 million
  • Duration
    24 months

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