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ADL-CU-19 Trial

ADU-CL-19 is a Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy. The primary objective of the trial is to assess the safety, pharmacokinetics and pharmacodynamics of BION-1301 in healthy volunteers and patients with IgAN.

The ADU-CL-19 Study

Chinook Therapeutics, Inc. is developing BION-1301,an investigational IgG4 humanized monoclonal antibody that blocks A Proliferation-Inducing Ligand, or APRIL. Studies have shown high levels of APRIL correlate with poor prognoses in patients with IgA nephropathy (IgAN), a chronic autoimmune kidney disease.

ADU-CL-19 is a Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy. The primary objective of the trial is to assess the safety, pharmacokinetics and pharmacodynamics of BION-1301 in healthy volunteers and patients with IgAN. 

In Part 3 of the trial, patients with IgAN will be randomized into two cohorts receiving BION-1301 at differing doses and frequency in an open-label manner. Enrolled patients will receive three months of dosing with BION-1301 (IV formulation) and three months of follow-up. The trial duration is expected to be 24 weeks with sites in both the US and UK. Patients enrolled in Part 3 of the study may be eligible to continue dosing for up to 24 months through participation in an Open Label Extension study the sponsor is opening.

If you are an adult patient with IgAN who meets these eligibility criteria and are interested in participating in this study, additional information may be found on ClinicalTrials.gov (Identifier: NCT03945318) and https://www.chinooktx.com/patients/iga-nephropathy/.