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CompletedNCT05083364Updated May 22, 2026

Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease

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

From the registry’s dates

  • Primary completion was Sep 2025, 1 year ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Apr 2026.
Phase
Phase 1/2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • C3 Glomerulopathy
  • IgA Nephropathy
03

In context

Glomerulonephritis, IGA

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria (All Participants):

  • Willing to provide written informed consent and to comply with study requirements
  • Female participants must be non-pregnant/non-lactating
  • Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. C3G and IgAN participants must have been vaccinated or willing to undergo vaccination
  • All participants must be willing to be vaccinated or have a history of vaccination for Haemophilus influenzae
  • Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
  • 12-lead electrocardiogram (ECG) at Screening with no abnormalities that may compromise participant's safety at discretion of investigator
  • Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Males must not donate sperm during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later.
  • No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the investigator, could adversely impact participant safety or study results

Inclusion Criteria (C3G and IgAN Participants):

  • Diagnosis of C3G or IgAN
  • Clinical evidence of ongoing disease based on significant proteinuria
  • Estimated glomerular filtration rate ≥30 mL/Min/1.73 m2 at Screening and currently not on dialysis
  • Must be on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

Exclusion Criteria (All Participants):

  • Seropositive for human immunodeficiency virus (HIV) infection,hepatitis B virus, or hepatitis C virus
  • History of recurrent or chronic infections
  • Uncontrolled hypertension
  • Regular use of alcohol within 30 days prior to Screening
  • Use of illicit drugs within 1 year prior to Screening or positive urine drug screen at Screening
  • History of meningococcal infection
  • History of asplenia or splenectomy
  • Known contraindication or history of anaphylactic reaction to any vaccine or vaccine component or prophylactic antibiotics planned for use in the study
  • Any medical or surgical condition that, in the opinion of the investigator, would expose the participant to a significant safety risk or compromise the results of the study

Note: Additional Inclusion/Exclusion criteria may apply per protocol

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    ARO-C3 (Healthy Volunteers)

    1 or 2 doses of ARO-C3 by subcutaneous (sc) injection

    Drug: ARO-C3

  • Placebo comparator
    Placebo (Healthy Volunteers)

    placebo calculated volume to match active treatment by sc injection

    Drug: Placebo

  • Experimental
    ARO-C3 (Adult Patients with C3G or IgAN)

    3 doses of ARO-C3 by sc injection

    Drug: ARO-C3

Interventions

  • DrugARO-C3

    ARO-C3 for sc injection

  • DrugPlacebo

    sterile normal saline (0.9% NaCl) for sc injection

06

What researchers measure

Primary outcomes

  1. 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])

Secondary outcomes

  1. Pharmacokinetics (PK) of ARO-C3: Maximum Observed Plasma Concentration (Cmax)

    Time frame: up to 48 hours post-dose

  2. 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

  3. 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

  4. 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

  5. PK of ARO-C3: Terminal Elimination Half-Life (t1/2)

    Time frame: up to 48 hours post-dose

  6. PK of ARO-C3: Apparent Total Body Clearance of ARO-C3 from Plasma (CL)

    Time frame: up to 48 hours post-dose

  7. PK of ARO-C3: Volume of Distribution (Vz/F)

    Time frame: up to 48 hours post-dose

07

Study locations

16 sites
  • Research Site 1
    Camperdown, New South Wales 2050, Australia
  • Research Site 3
    Concord, New South Wales 2139, Australia
  • Research Site 2
    Clayton, Victoria 3168, Australia
  • Research Site 2
    Tbilisi, 0112, Georgia
  • Research Site 2
    Cologne, 50937, Germany
  • Research Site 4
    Erlangen, 91054, Germany
  • Research Site
    Auckland, 1010, New Zealand
  • Research Site 1
    Gamcheon, Busan 49267, South Korea
  • Research Site 2
    Haeundae, Busan 48108, South Korea
  • Research Site 4
    Goyang-si, Gyeonggi-do 10444, South Korea
  • Research Site 3
    Daegu, 42601, South Korea
  • Research Site 6
    Soeul, 03722, South Korea
  • Research Site 8
    Soeul, 05030, South Korea
  • Research Site 2
    Bangkok, 10400, Thailand
  • Research Site 3
    Chiang Mai, 50200, Thailand
  • Research Site 4
    Oxford, OX3 7LE, United Kingdom
08

References and documents

Publications

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3. PubMed 38299639 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05083364
Lead sponsor
Arrowhead Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 19, 2021
Start date
Feb 1, 2022
Primary completion
Sep 10, 2025
Completion
Sep 10, 2025
Last update
May 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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