Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging
Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Preclinical evidence has shown that NP41 is a novel nerve-binding peptide with safe
pharmacokinetics. Fluorescently labeled NP41 is effective for the intraoperative
visualization of cranial nerves during neurosurgery. This Phase I/II clinical trial is aimed
to investigate the safety and validity of FAM-NP41 for the fluorescence imaging of cranial
nerves. In the Phase I trial, biological safety and adverse events will be evaluated, and
pharmacokinetic parameters will be measured. In the Phase II trial, the sensitivity and
specificity of FAM-NP41 for the fluorescence imaging of cranial nerves will be investigated,
and the signal-to-background ratio will be calculated.