Academia and industry agreement on a feasibility tool for first-time-in-human clinical trial units

Clin Transl Sci. 2023 Oct 11. doi: 10.1111/cts.13655. Online ahead of print. ABSTRACT First-time-in-human (FTIH) trials are designed to generate information on the safety, tolerability, as well as the pharmacokinetic and pharmacodynamics profile of new drugs. To ensure the safety of participants, these trials need to be conducted at specifically equipped phase I clinical trial…