NCT05043519

Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging

Phase I/II Clinical Trial of NP41 Molecular Targeted Fluorescence Imaging for Cranial Nerve Visualization During Neurosurgery

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cranial Nerve Injuries

Interventions

Type	Name	Description
DRUG	FAM-NP41	The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-08-31
• Completion: 2023-12-31
• First posted: 2021-09-14
• Last updated: 2021-09-14