A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT

Phase 2 Recruiting 84 enrolled Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 75 years old with PWB will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.

Timeline

Start: 2024-09-21
Primary completion: 2027-01
Completion: 2027-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hematoporphyrin	Small molecule	5 mg/kg	Intravenous

Indications

No indication recorded.