Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
660
Trial Sponsor
Clinical Trial Start Date
2024
0Primary Completion Date
2026
0Study Completion Date
2027
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
Placebo0
ARO-CFB0
Interventional Trial Phase
Phase 10
Official Name
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 Disease0
Last Updated
January 17, 2024
0Allocation Type
Randomized0
Intervention Model
Sequential Assignment0
Masking Type
Quadruple0
Masked Party
Participant0
Outcomes Assessor0
Investigator0
Care Provider0
Other attributes
Intervention Treatment
ARO-CFB0
Placebo0
Study summary
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs) and in adult patients with complement-mediated kidney disease (IgA Nephropathy \[IgAN\]). In Part 1 of the study, HVs will receive either one or two doses of ARO-CFB or placebo. In Part 2 of the study, adult patients with IgAN will receive 3 open-label doses of ARO-CFB. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
Timeline
No Timeline data yet.
Further Resources
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