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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARO-CFB (Healthy Volunteers) | Experimental | 1 or 2 doses of ARO-CFB by subcutaneous (sc) injection |
|
| Placebo (Healthy Volunteers) | Experimental | placebo calculated volume to match active treatment by sc injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-CFB | Drug | ARO-CFB for sc injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | up to Day 169 (End of Study [EOS]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Additional Inclusion/Exclusion criteria may apply per protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Auckland | 1010 | New Zealand |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Participants are randomized to receive either ARO-CFB or placebo. Participants, care providers, investigator and outcomes assessors are all blinded to treatment assignment.
| Placebo |
| Drug |
sterile normal saline (0.9% NaCl for sc injection) |
|
| 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 |
| PK of ARO-CFB: Terminal Elimination Half-Life (t1/2) | up to 48 hours post-dose |
| PK of ARO-CFB: Apparent Clearance (CL/F) | up to 48 hours post-dose |
| PK of ARO-CFB: Volume of Distribution (Vz/F) | up to 48 hours post-dose |
| PK of ARO-CFB: Amount of Drug Recovered in Urine Over Zero - 24 Hours Post-dose (Ae) | up to 24 hours post-dose |
| PK of ARO-CFB: Fraction of Drug Excreted Unchanged (fe) | up to 24 hours post-dose |
| PK of ARO-CFB: Renal Clearance (CLr) | up to 24 hours post-dose |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |