Study of ARO-CFB in Adult Healthy Volunteers

NCT06209177 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AROCFB-1001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

  up to Day 169 (End of Study [EOS])

Secondary Outcomes (11)

• Pharmacokinetics (PK) of ARO-CFB: Maximum Observed Plasma Concentration (Cmax)

  up to 48 hours postdose

• PK of ARO-CFB: Time to Maximum Observed Plasma Concentration (Tmax)

  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)

  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)

  up to 48 hours post-dose

• PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)

  up to 48 hours post-dose

Study Arms (2)

ARO-CFB (Healthy Volunteers)

EXPERIMENTAL

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

Drug: ARO-CFB

Placebo (Healthy Volunteers)

EXPERIMENTAL

placebo calculated volume to match active treatment by sc injection

Drug: Placebo

Interventions

ARO-CFB DRUG

ARO-CFB for sc injection

ARO-CFB (Healthy Volunteers)

Placebo DRUG

sterile normal saline (0.9% NaCl for sc injection)

Placebo (Healthy Volunteers)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Known or suspected hereditary complement deficiency or other primary immunodeficiency syndrome
• History of diabetes mellitus (Type 1 or Type 2)
• Uncontrolled hypertension

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site

Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are randomized to receive either ARO-CFB or placebo. Participants, care providers, investigator and outcomes assessors are all blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: April 5, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)