Feldan Therapeutics
The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and Maximum Tolerable Dose (MTD), of intralesional FLD-103 when administered to subjects with Basal Cell Carcinoma (BCC). The main questions it aims to answer are: * Is FLD-103 safe and well tolerated? * What is a safe dose of FLD-103 for future studies? * How much FLD-103 enters the bloodstream and how long does it take to be cleared from the body? * Does FLD-103 reduce the size of the tumor? Participants will: * Receive either a Single Ascending Dose (SAD) of FLD-103 or Multiple Ascending Doses (MAD) of FLD-103 once weekly for four (4) weeks. * Visit the clinic a day after receiving a dose and once weekly for four (4) weeks after that for checkups and tests.
Inclusion Criteria: * You are between 18 and 85 years old. * You are willing to attend all study visits and follow the study procedures. * You have been diagnosed with at least one nodular basal cell carcinoma (a type of skin cancer) that has never been treated and suitable for treatment and final excision by the Investigator. * You are willing to avoid certain medications during the study as instructed by the study doctor. * You are not currently participating in another clinical study. * If you are a woman who could become pregnant, you must: * Have a negative pregnancy test at the start of…
Intralesional and perilesional injection of FLD-103