First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers

NM8074 is a novel, recombinant, humanized monoclonal antibody. NM8074 selectively binds to human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP) driven C3 and C5 convertases. Both C3 and C5 convertases are critical for exacerbation and amplification of the AP in complement-mediated disorders. 06-101-FIH-NM8074 is the first-in-human clinical trial for NM8074 which is intended to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 when delivered as a single intravenous infusion to healthy volunteers. Doses will be escalated in each of the 5 sequential cohorts using sentinel dosing.