Northeast Clinical Research Center | Bethlehem, PA
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About
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).
Full description
This is a Phase 1/2 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody.
The study will be conducted in three parts. Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs). Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs. Part 3: Open-label, multiple dose (MD) in participants with IgAN. Part 4: Retreatment period
Parts 1 and 2 have been completed. Part 3 enrollment is complete. Part 4 enrollment is open for eligible participants from Part 3.
The study will enroll up to 40 participants with IgAN.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria for Healthy Volunteers:
Exclusion Criteria for Healthy Volunteers:
Inclusion Criteria for Adults with IgAN:
Exclusion Criteria for Adults with IgAN:
PART 4 Eligibility Criteria for Re-treatment Due to Evidence of Disease Progression (Option 1) Inclusion Criteria for Re-treatment Due to Evidence of Disease Progression
Exclusion Criteria for Re-treatment Due to Evidence of Disease Progression
Eligibility Criteria for Optional Re-treatment (Option 2) Inclusion Criteria for Optional Re-treatment 1. Completed Part 3 of the study through Week 124 and completed of the 52-week follow-up period.
Exclusion Criteria for Optional Re-treatment
Primary purpose
Allocation
Interventional model
Masking
103 participants in 6 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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