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OpenTrials
Completed

NCT Number: NCT06209177

Study of ARO-CFB in Adult Healthy Volunteers

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Auckland, 1010, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Treatment and study plan

ARO-CFB

Drug

ARO-CFB for sc injection

Placebo

Drug

sterile normal saline (0.9% NaCl for sc injection)

Primary outcomes

  1. 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])

Secondary outcomes

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

    Time frame: up to 48 hours postdose

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

    Time frame: up to 48 hours post-dose

  3. 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

  4. 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

  5. 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

  6. PK of ARO-CFB: Terminal Elimination Half-Life (t1/2)

    Time frame: up to 48 hours post-dose

  7. PK of ARO-CFB: Apparent Clearance (CL/F)

    Time frame: up to 48 hours post-dose

  8. PK of ARO-CFB: Volume of Distribution (Vz/F)

    Time frame: up to 48 hours post-dose

  9. 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

  10. PK of ARO-CFB: Fraction of Drug Excreted Unchanged (fe)

    Time frame: up to 24 hours post-dose

  11. PK of ARO-CFB: Renal Clearance (CLr)

    Time frame: up to 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 17, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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