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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506690-36-00 | EU Trial (CTIS) Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARO-C3 (Healthy Volunteers) | Experimental | 1 or 2 doses of ARO-C3 by subcutaneous (sc) injection |
|
| Placebo (Healthy Volunteers) | Placebo Comparator | placebo calculated volume to match active treatment by sc injection |
|
| ARO-C3 (Adult Patients with C3G or IgAN) | Experimental | 3 doses of ARO-C3 by sc injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-C3 | Drug | ARO-C3 for sc injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Day 169 | up to day 169 (End of Study [EOS]) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ARO-C3: Maximum Observed Plasma Concentration (Cmax) | up to 48 hours post-dose | |
| PK of ARO-C3: Area under the Plasma Concentration Versus Time Curve from Zero to 24Hours (AUC0-24) | up to 48 hours post-dose |
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Inclusion Criteria (All Participants):
Inclusion Criteria (C3G and IgAN Participants):
Exclusion Criteria (All Participants):
Note: Additional Inclusion/Exclusion criteria may apply per protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 1 | Camperdown | New South Wales | 2050 | Australia | ||
| Research Site 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38299639 | Derived | Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3. |
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Part 1, participants are randomized to receive either ARO-C3 or placebo. Participants,care providers, investigator and outcomes assessors are all blinded to treatment assignment. Part 2 in patients with C3G or IgAN is open-label and there is no masking.
| Placebo | Drug | sterile normal saline (0.9% NaCl) for sc injection |
|
| PK of ARO-C3: Area Under the Plasma Versus Time Concentration Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast) | up to 48 hours post-dose |
| PK of ARO-C3: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf) PK of ARO-C3: | up to 48 hours post-dose |
| PK of ARO-C3: Terminal Elimination Half-Life (t1/2) | up to 48 hours post-dose |
| PK of ARO-C3: Apparent Total Body Clearance of ARO-C3 from Plasma (CL) | up to 48 hours post-dose |
| PK of ARO-C3: Volume of Distribution (Vz/F) | up to 48 hours post-dose |
| Concord |
| New South Wales |
| 2139 |
| Australia |
| Research Site 2 | Clayton | Victoria | 3168 | Australia |
| Research Site 2 | Tbilisi | 0112 | Georgia |
| Research Site 2 | Cologne | 50937 | Germany |
| Research Site 4 | Erlangen | 91054 | Germany |
| Research Site | Auckland | 1010 | New Zealand |
| Research Site 1 | Gamcheon | Busan | 49267 | South Korea |
| Research Site 2 | Haeundae | Busan | 48108 | South Korea |
| Research Site 4 | Goyang-si | Gyeonggi-do | 10444 | South Korea |
| Research Site 3 | Daegu | 42601 | South Korea |
| Research Site 6 | Soeul | 03722 | South Korea |
| Research Site 8 | Soeul | 05030 | South Korea |
| Research Site 2 | Bangkok | 10400 | Thailand |
| Research Site 3 | Chiang Mai | 50200 | Thailand |
| Research Site 4 | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |
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