Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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.
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 cycles at fixed drug dose (5 mg/kg) and different light fluences. This study will be conducted in two sequential stages, each contains the same schedule, which includes Screening Period, Treatment Period apart; subsequent treatment is based on efficacy evaluation, and End of Study.
Inclusion Criteria: 1. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent. 2. Subject is Fitzpatrick skin type I-VI. 3. A male subject must agree to use contraception during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period. 4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow the contraceptive…
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.