Initiator Pharma A/S, a clinical-stage pharma company, announced today that it will initiate a Phase I pharmacokinetic study in healthy subects evaluating new oral solid dosage forms enabling a bridging between previous data sets into new future clinical studies for IP2015.
The Phase I study will be an open labelled randomized study in 12 healthy subjects evaluating current and new oral solid dosage formulations of IP2015. It was approved by the British Regularotory Authorities, MHRA and the Ethics Committee and is expected to start in the beginning of 2023 and provide draft phamacokinetic data in Q2 2023. The study will also strengthen the intellectual property rights (IPR) portfolio for the entire IP2015 program.
“I am pleased with the approval of the Phase I pharmacokinetics study and look forward to getting started after the holidays. This study is vital in designing and executing future clinical development studies for IP2015. Furthermore, the solid dosage formulation brings us closer to having a final drug product that may be used in a potential future launch,” says Claus Elsborg Olesen, CEO at Initiator Pharma.