The European Medicines Agency (EMEA) has drafted guidelines to help ensure the safety of subjects enrolling in first-in-man studies. The guidelines come on the heels of TeGenero’s trial, which caused six otherwise healthy phase I subjects to suffer severe adverse reactions after being administered an immunological agent at a hospital in the United Kingdom. Following the incident, reviews were performed on how the study was conducted and concluded it satisfied current regulatory requirements. Among the many items cited in the report, the EMEA recommends that the Minimal Anticipated Biological Effect Level—or MABEL—be used when testing “high risk products” such as monoclonal antibodies in phase I trials.
The draft is open to a two-month public-consultation period, after which the EMEA will hold meetings with industry, academic researchers, regulatory bodies and healthcare professionals to hear feedback. The final guidance will released following that process.