NCT05083364CompletedPhase 1/2
Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Complement-Mediated Renal Disease
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 8 Oct 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 10 Sept 2025
- Lead sponsor
- Arrowhead Pharmaceuticals
- Diseases
- IgA nephropathy
- NCT number
- NCT05083364
- EU CT number
- 2023-506690-36-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 62
- From 1 Feb 2022 to the primary completion date, 10 Sept 2025
- 16 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Seropositive for human immunodeficiency virus (HIV) infection,hepatitis B virus, or hepatitis C virus
- History of recurrent or chronic infections
- Uncontrolled hypertension
- 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
Who the study is looking for
- 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
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site 1 Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Research Site 2 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Research Site 3 Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| Research Site 2 Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Research Site 4 Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Research Site 4 Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Research Site 2 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Research Site 3 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Research Site 1 Coordinator of this site? Confirm its status | Gamcheon | South Korea | Unknown status |
| Research Site 4 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Research Site 2 Coordinator of this site? Confirm its status | Haeundae | South Korea | Unknown status |
| Research Site 8 Coordinator of this site? Confirm its status | Soeul | South Korea | Unknown status |
| Research Site 6 Coordinator of this site? Confirm its status | Soeul | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Research Site 2 Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Research Site 3 Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.