A Phase 1/2 interventional study of ARO-C3 and Placebo in C3 Glomerulopathy and IgA Nephropathy, sponsored by Arrowhead Pharmaceuticals. Completed at 16 sites in 7 countries. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Arrowhead Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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.
254 studies on the registry are indexed under Glomerulonephritis, IGA; 100 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 206 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Arrowhead Pharmaceuticals is the lead sponsor of 50 studies on the registry; 10 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (All Participants):
Inclusion Criteria (C3G and IgAN Participants):
Exclusion Criteria (All Participants):
Note: Additional Inclusion/Exclusion criteria may apply per protocol
1 or 2 doses of ARO-C3 by subcutaneous (sc) injection
Drug: ARO-C3
placebo calculated volume to match active treatment by sc injection
Drug: Placebo
3 doses of ARO-C3 by sc injection
Drug: ARO-C3
ARO-C3 for sc injection
sterile normal saline (0.9% NaCl) for sc injection
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
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Arrowhead Pharmaceuticals