NCT06209177CompletedPhase 1
Study of ARO-CFB in Adult Healthy Volunteers
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ARO-CFB in Adult Healthy Volunteers and Adult Patients With Complement-Mediated Kidney Disease
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs). HVs will receive either one or two doses of ARO-CFB or placebo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 5 Jan 2024
- Start date
- 5 Apr 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Arrowhead Pharmaceuticals
- Diseases
- IgA nephropathy
- NCT number
- NCT06209177
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 49
- From 5 Apr 2024 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- 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
- History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
- History of severe aplastic anemia or concurrent severe aplastic anemia
Other illness
- History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
- Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- History of meningococcal infection
- History of asplenia
- Known or suspected hereditary complement deficiency or other primary immunodeficiency syndrome
- History of diabetes mellitus (Type 1 or Type 2)
- Uncontrolled hypertension
- 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. 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 type B
- Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
- Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or the last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study and for at least 90 days 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 adversely impact study results.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.