Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

Summary

Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).

Timeline

Start

2019-04-08

Primary completion

2026-06-10

Completion

2026-06-10

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “One Year of Zigakibart Treatment Shows Clinically Meaningful Proteinuria Reduction and Good Tolerability in a Phase 1/2 Study of IgA Nephropathy.” novartis.com ↗

release “Updated results from the Phase I/II study for zigakibart in IgAN showed a robust and clinically meaningful reduction in proteinuria” novartis.com ↗

release “Long-term data from the Phase I/II study of zigakibart showed durable reductions in disease-relevant biomarkers” novartis.com ↗

Publications

• Kooienga L, Lo J, Lee EY, Kim SG, Thomas H, Workeneh B, Agha I, Song Y, Smith W, van Eenennaam H, Van Elsas A, Dulos J, Barratt J. Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. Kidney Int. 2025 Sep;108(3):445-454. doi: 10.1016/j.kint.2025.05.006. Epub 2025 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	zigakibart	Monoclonal antibody	10 mg	Intravenous
Subject	zigakibart	Monoclonal antibody	50 mg	Intravenous
Subject	zigakibart	Monoclonal antibody	150 mg	Intravenous
Subject	zigakibart	Monoclonal antibody	450 mg	Intravenous
Subject	zigakibart	Monoclonal antibody	600 mg	Intravenous
Subject	zigakibart	Monoclonal antibody	1350 mg	Intravenous

Indications