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

Last updated: December 12, 2025
Sponsor: Arrowhead Pharmaceuticals
Overall Status: Completed

Phase

1/2

Condition

Nephropathy

Kidney Disease

Glomerulonephritis

Treatment

ARO-C3

Placebo

Clinical Study ID

NCT05083364
AROC3-1001
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: ARO-C3
Phase: 1/2
Study Start date:
February 01, 2022
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Research Site 1

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Research Site 3

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Research Site 1

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Research Site 3

    Concord 2170852, New South Wales 2155400 2139
    Australia

    Site Not Available

  • Research Site 2

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Research Site 2

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Research Site 1

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Research Site 2

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Research Site 3

    Tbilisi, 0186
    Georgia

    Site Not Available

  • Research Site 2

    Tbilisi 611717, 0112
    Georgia

    Site Not Available

  • Research Site 2

    Cologne, 50937
    Germany

    Site Not Available

  • Research Site 2

    Cologne 2886242, 50937
    Germany

    Site Not Available

  • Research Site 4

    Erlangen, 91054
    Germany

    Site Not Available

  • Research Site 4

    Erlangen 2929567, 91054
    Germany

    Site Not Available

  • Research Site 3

    Halle, 06120
    Germany

    Site Not Available

  • Research Site 1

    Mainz, 55131
    Germany

    Site Not Available

  • Research Site 1

    Gamcheon, Busan 49267
    Korea, Republic of

    Site Not Available

  • Research Site 2

    Haeundae, Busan 48108
    Korea, Republic of

    Site Not Available

  • Research Site 4

    Goyang-si, Gyeonggi-do 10444
    Korea, Republic of

    Site Not Available

  • Research Site 5

    Seongnam, Gyeonggi-do 13496
    Korea, Republic of

    Site Not Available

  • Research Site 1

    Busan, 49267
    Korea, Republic of

    Site Not Available

  • Research Site 2

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Research Site 4

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Research Site 3

    Daegu, 42601
    Korea, Republic of

    Site Not Available

  • Research Site 4

    Goyang, 10444
    Korea, Republic of

    Site Not Available

  • Research Site 9

    Gyeonggi-do, 10444
    Korea, Republic of

    Site Not Available

  • Research Site 8

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Research Site 9

    Seoul, 6591
    Korea, Republic of

    Site Not Available

  • Research Site 5

    Soeul, 5505
    Korea, Republic of

    Site Not Available

  • Research Site 6

    Soeul, 03722
    Korea, Republic of

    Site Not Available

  • Research Site 7

    Soeul, 08308
    Korea, Republic of

    Site Not Available

  • Research Site 8

    Soeul, 05030
    Korea, Republic of

    Site Not Available

  • Research Site

    Auckland, 1010
    New Zealand

    Site Not Available

  • Research Site

    Auckland 2193733, 1010
    New Zealand

    Site Not Available

  • Research Site 1

    Gamcheon, Busan 1838519 49267
    South Korea

    Site Not Available

  • Research Site 2

    Haeundae 1844708, Busan 1838519 48108
    South Korea

    Site Not Available

  • Research Site 3

    Daegu 1835329, Daegu 1835327 42601
    South Korea

    Site Not Available

  • Research Site 4

    Goyang-si 1842485, Gyeonggi-do 1841610 10444
    South Korea

    Site Not Available

  • Research Site 6

    Soeul 6808867, 03722
    South Korea

    Site Not Available

  • Research Site 8

    Soeul 6808867, 05030
    South Korea

    Site Not Available

  • Research Site 1

    Barcelona, 08003
    Spain

    Site Not Available

  • Research Site 2

    Barcelona, 08035
    Spain

    Site Not Available

  • Research Site 3

    Madrid, 28015
    Spain

    Site Not Available

  • Research Site 1

    Bangkok, 10330
    Thailand

    Site Not Available

  • Research Site 2

    Bangkok, 10400
    Thailand

    Site Not Available

  • Research Site 4

    Bangkok, 10700
    Thailand

    Site Not Available

  • Research Site 2

    Bangkok 1609350, 10400
    Thailand

    Site Not Available

  • Research Site 3

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Research Site 3

    Chiang Mai 1153671, 50200
    Thailand

    Site Not Available

  • Research Site 6

    Hat Yai, 90110
    Thailand

    Site Not Available

  • Research Site 5

    Cambridge, CB20QQ
    United Kingdom

    Site Not Available

  • Research Site 2

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Research Site 1

    Leicester, LE1 SWW
    United Kingdom

    Site Not Available

  • Research Site 3

    Liverpool, L7 8YE
    United Kingdom

    Site Not Available

  • Research Site 6

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

  • Research Site 4

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Research Site 4

    Oxford 2640729, OX3 7LE
    United Kingdom

    Site Not Available

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