Status and phase
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About
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs) and in adult patients with complement-mediated kidney disease (IgA Nephropathy [IgAN]). In Part 1 of the study, HVs will receive either one or two doses of ARO-CFB or placebo. In Part 2 of the study, adult patients with IgAN will receive 3 open-label doses of ARO-CFB. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria (All Participants):
Inclusion Criteria (IgAN Participants):
Exclusion Criteria (All Cohorts):
Exclusion Criteria (IgAN Participants):
Note: Additional Inclusion/Exclusion criteria may apply per protocol
Primary purpose
Allocation
Interventional model
Masking
66 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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