The purpose of AROC3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (HVs) and in adult patients with complement-mediated renal disease (C3 Glomerulopathy \[C3G\] and IgA Nephropathy \[IgAN\]). In Part 1 of the study, HVs will receive either one or two doses of ARO-C3 or placebo. In Part 2 of the study, adult patients with C3G/IgAN will receive 3 open-label doses of ARO-C3. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
ARO-C3 for sc injection
sterile normal saline (0.9% NaCl) for sc injection
Research Site 1
Camperdown, New South Wales, Australia
Research Site 3
Concord, New South Wales, Australia
Research Site 2
Clayton, Victoria, Australia
Research Site 2
Tbilisi, Georgia
Research Site 2
Cologne, Germany
Research Site 4
Erlangen, Germany
Research Site
Auckland, New Zealand
Research Site 1
Gamcheon, Busan, South Korea
Research Site 2
Haeundae, Busan, South Korea
Research Site 3
Daegu, Daegu, South Korea
...and 6 more locations
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Day 169
Time frame: up to day 169 (End of Study [EOS])
Pharmacokinetics (PK) of ARO-C3: Maximum Observed Plasma Concentration (Cmax)
Time frame: up to 48 hours post-dose
PK of ARO-C3: Area under the Plasma Concentration Versus Time Curve from Zero to 24Hours (AUC0-24)
Time frame: up to 48 hours post-dose
PK of ARO-C3: Area Under the Plasma Versus Time Concentration Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)
Time frame: up to 48 hours post-dose
PK of ARO-C3: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf) PK of ARO-C3:
Time frame: up to 48 hours post-dose
PK of ARO-C3: Terminal Elimination Half-Life (t1/2)
Time frame: up to 48 hours post-dose
PK of ARO-C3: Apparent Total Body Clearance of ARO-C3 from Plasma (CL)
Time frame: up to 48 hours post-dose
PK of ARO-C3: Volume of Distribution (Vz/F)
Time frame: up to 48 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.