First-in-Human Clinical Study

In designing the first study B4D will consider both the competitive and regulatory landscape and include not only evaluations of safety and dose-finding but endpoints which provide proof of concept for target engagement. This provides the necessary information for determining the design and sample size of subsequent studies as well as support fundraising efforts. B4D will assemble a Clinical Advisory Board (CAB) consisting of clinical experts in the indicated therapeutic area to develop this novel FIH protocol. B4D will refine the protocol by engaging regulatory authorities in Pre-IND/CTA meetings prior to filing the IND/CTA.