Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Status:
Completed
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Bioverativ, a Sanofi company True North Therapeutics
Collaborators:
ABF Pharmaceutical Services GmbH Assign Clinical Research GmbH Assign Data Management and Biostatistics GmbH Celerion Clinical Research GmbH Covance Laboratories - Chantilly PPD Laboratories - Virginia Quest Diagnostics Quest Diagnostics-Nichols Insitute Softworld Inc. - Cambridge, MA Vela Laboratories