103
Participants
Start Date
April 8, 2019
Primary Completion Date
October 1, 2025
Study Completion Date
April 13, 2026
BION-1301 Single Dose
A solution for IV infusion administered as a single dose.
Placebo Single Dose
A solution by IV infusion administered as a single dose.
BION-1301 Multiple Doses
A solution for IV infusion or SC injections (Part 3 only) administered as multiple doses.
Placebo Multiple Doses
A solution by IV infusion administered as multiple doses.
BION-1301 Single Dose
SC injection administration as a single dose using vials or pre-filled syringes (PFS) (Part 4 only).
National Health Insurance Service Ilsan Hospital, Goyang-si
Hanyang University Guri Hostpital, Guri-si
New York Nephrology, Clifton Park
Seoul National University Bundang Hospital, Seongnam-si
Hallym University Sacred Heart Hospital, Anyang-si
Soon Chun Hyang University Hospital Cheonan, Cheonan
Nephrology Associates of Central Florida, Orlando
Elixia Tampa, LLC, Tampa
Chris Sholer, P.C., Oklahoma City
Liberty Research Center, Dallas
Liberty Research Center, Arlington
Prolato Clinical Research Center, Houston
Colorado Kidney Care, P.C., Denver
Amicis Research Center, Northridge
Liverpool University Hospital NHS Foundation Trust, Liverpool
PAREXEL Early Phase Clinical Unit, London
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY