Proof-of-Concept trials in patients using adequate pharmacodynamic endpoints should not be initiated before an adequate phase-I program has been completed in healthy subjects and all safety and exposure data in healthy subjects have been thoroughly reviewed. Sufficient safety and exposure data should be obtained in healthy subjects beforehand to determine the dose range to be investigated in patients. In the context of a PoC trial, a dose escalation study in patients can be useful. On the other hand, not too many dose steps should be investigated in patients, in order not to expose too many patients.
Special cases are PoC trials in healthy subjects that use appropriate biomarkers or quantify a drug effect that can also be measured in healthy subjects, or pharmacodynamic studies in healthy subjects or patients in which a certain, abnormal condition is artificially induced to enable the measurement of a drug effect. INAMED has a long history of conducting PoC trials in patients, including allergen challenge studies or other provocation models in patients with asthma that offer the chance to obtain a PoC signal at an early stage [Link]. However, there are more intelligent approaches to achieve an early PoC even in other indications.
If deemed useful, WARP’s established collaboration with academic and laboratory partners will facilitate implementation and validation of experimental assays in early stages of development. Inamed’s clinical pharmacology experts would be pleased to provide medical advice with regard to contents and will set up a clinical study protocol for you. Inamed will facilitate the efficient clinical conduct of your PoC trial as a mono-centre study, if possible, or in a multi-centre setting under standardized conditions.