IgA NephropathyPhase 1NCT06209177
Study of ARO-CFB in Adult Healthy Volunteers
A Phase 1 study testing ARO-CFB in people with IgA Nephropathy, run by Arrowhead Pharmaceuticals at 1 site in New Zealand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- ARO-CFB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteNew Zealand
- Study dates
- 5 Apr 2024to 6 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
- History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
- Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- History of meningococcal infection
- History of asplenia
- History of severe aplastic anemia or concurrent severe aplastic anemia
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- IgA Nephropathy
- Being tested
- ARO-CFB, Placebo
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-CFBDrug
ARO-CFB for sc injection
PlaceboDrug
sterile normal saline (0.9% NaCl for sc injection)
| Study group | Role | What they receive |
|---|---|---|
| ARO-CFB (Healthy Volunteers) | Experimental | 1 or 2 doses of ARO-CFB by subcutaneous (sc) injection Receives: Drug: ARO-CFB |
| Placebo (Healthy Volunteers) | Experimental | placebo calculated volume to match active treatment by sc injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Measured: up to Day 169 (End of Study [EOS])
Secondary outcomes (11)
Pharmacokinetics (PK) of ARO-CFB: Maximum Observed Plasma Concentration (Cmax)
Measured: up to 48 hours postdose
PK of ARO-CFB: Time to Maximum Observed Plasma Concentration (Tmax)
Measured: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Measured: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)
Measured: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)
Measured: up to 48 hours post-dose
PK of ARO-CFB: Terminal Elimination Half-Life (t1/2)
Measured: up to 48 hours post-dose
PK of ARO-CFB: Apparent Clearance (CL/F)
Measured: up to 48 hours post-dose
PK of ARO-CFB: Volume of Distribution (Vz/F)
Measured: up to 48 hours post-dose
PK of ARO-CFB: Amount of Drug Recovered in Urine Over Zero - 24 Hours Post-dose (Ae)
Measured: up to 24 hours post-dose
PK of ARO-CFB: Fraction of Drug Excreted Unchanged (fe)
Measured: up to 24 hours post-dose
PK of ARO-CFB: Renal Clearance (CLr)
Measured: up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start5 Apr 2024
- Primary completion31 Mar 2025
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209177
- Sponsor's protocol ID
- AROCFB-1001
- Status last verified
- May 2026
- First submitted
- 5 Jan 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06209177
- Acronym / sponsor ID
- AROCFB-1001
- Conditions
- IgA Nephropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARO-CFB (Healthy Volunteers) | Experimental | Drug: ARO-CFB1 or 2 doses of ARO-CFB by subcutaneous (sc) injection |
| Placebo (Healthy Volunteers) | Experimental | Drug: Placeboplacebo calculated volume to match active treatment by sc injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
- History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
- Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- History of meningococcal infection
- History of asplenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARO-CFBARO-CFB for sc injection | Drug | ARO-CFB (Healthy Volunteers) |
| Placebosterile normal saline (0.9% NaCl for sc injection) | Drug | Placebo (Healthy Volunteers) |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Time frame: up to Day 169 (End of Study [EOS])
11 secondary outcomes
Pharmacokinetics (PK) of ARO-CFB: Maximum Observed Plasma Concentration (Cmax)
Time frame: up to 48 hours postdose
PK of ARO-CFB: Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Terminal Elimination Half-Life (t1/2)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Apparent Clearance (CL/F)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Volume of Distribution (Vz/F)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Amount of Drug Recovered in Urine Over Zero - 24 Hours Post-dose (Ae)
Time frame: up to 24 hours post-dose
PK of ARO-CFB: Fraction of Drug Excreted Unchanged (fe)
Time frame: up to 24 hours post-dose
PK of ARO-CFB: Renal Clearance (CLr)
Time frame: up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARO-CFB in people with IgA Nephropathy, run by Arrowhead Pharmaceuticals at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) (time frame: up to Day 169 (End of Study [EOS])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.