Softworld, Inc.

Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder, and Part E, a multiple dose (MD) study in patients with cold agglutinin disease previously treated with BIVV009 within the scope of a BIVV009 clinical trial or named patient program use. Note: For parts A-C as well as at the start of part E, study drug was named TNT009. The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.