ARO-C3
DrugARO-C3 for sc injection
NCT Number: NCT05083364
The purpose of AROC3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (HVs) and in adult patients with complement-mediated renal disease (C3 Glomerulopathy [C3G] and IgA Nephropathy [IgAN]). In Part 1 of the study, HVs will receive either one or two doses of ARO-C3 or placebo. In Part 2 of the study, adult patients with C3G/IgAN will receive 3 open-label doses of ARO-C3. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1 / Phase 2
Research Site 1, Camperdown, New South Wales, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(All Participants):
Inclusion criteria
(C3G and IgAN Participants):
Exclusion criteria
(All Participants):
Note: Additional Inclusion/Exclusion criteria may apply per protocol
ARO-C3 for sc injection
sterile normal saline (0.9% NaCl) for sc injection
Time frame: up to day 169 (End of Study [EOS])
Time frame: up to 48 hours post-dose
Time frame: up to 48 hours post-dose
Time frame: up to 48 hours post-dose
Time frame: up to 48 hours post-dose
Time frame: up to 48 hours post-dose
Time frame: up to 48 hours post-dose
Time frame: up to 48 hours post-dose
Arrowhead Pharmaceuticals
Industry
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Complement-Mediated Renal Disease
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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