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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05083364
Other study ID # AROC3-1001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 2, 2022
Est. completion date June 2025

Study information

Verified date April 2024
Source Arrowhead Pharmaceuticals
Contact Clinical Operations Lead
Phone 626-304-3400
Email ARO-C3@arrowheadpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria (All Participants): - 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. C3G and 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 - Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 - 12-lead electrocardiogram (ECG) at Screening with no abnormalities that may compromise participant's safety at discretion of investigator - Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Males must not donate sperm during the study and for at least 12 weeks 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 study results Inclusion Criteria (C3G and IgAN Participants): - Diagnosis of C3G or IgAN - Clinical evidence of ongoing disease based on significant proteinuria - Estimated glomerular filtration rate =30 mL/Min/1.73 m2 at Screening and currently not on dialysis - Must be on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) Exclusion Criteria (All Participants): - Seropositive for human immunodeficiency virus (HIV) infection,hepatitis B virus, or hepatitis C virus - History of recurrent or chronic infections - Uncontrolled hypertension - Regular use of alcohol within 30 days prior to Screening - Use of illicit drugs within 1 year prior to Screening or positive urine drug screen at Screening - History of meningococcal infection - History of asplenia or splenectomy - Known contraindication or history of anaphylactic reaction to any vaccine or vaccine component or prophylactic antibiotics planned for use in the study - Any medical or surgical condition that, in the opinion of the investigator, would expose the participant to a significant safety risk or compromise the results of the study Note: Additional Inclusion/Exclusion criteria may apply per protocol

Study Design


Intervention

Drug:
ARO-C3
ARO-C3 for sc injection
Placebo
sterile normal saline (0.9% NaCl) for sc injection

Locations

Country Name City State
Australia Research Site 1 Camperdown New South Wales
Australia Research Site 2 Clayton Victoria
Australia Research Site 3 Concord New South Wales
Georgia Research Site 1 Tbilisi
Georgia Research Site 2 Tbilisi
Georgia Research Site 3 Tbilisi
Germany Research Site 2 Cologne
Germany Research Site 4 Erlangen
Germany Research Site 3 Halle
Germany Research Site 1 Mainz
Korea, Republic of Research Site 3 Daegu
Korea, Republic of Research Site 1 Gamcheon Busan
Korea, Republic of Research Site 4 Goyang-si Gyeonggi-do
Korea, Republic of Research Site 2 Haeundae Busan
Korea, Republic of Research Site 5 Seongnam Gyeonggi-do
Korea, Republic of Research Site 6 Soeul
Korea, Republic of Research Site 7 Soeul
Korea, Republic of Research Site 8 Soeul
New Zealand Research Site Auckland
Thailand Research Site 1 Bangkok
Thailand Research Site 2 Bangkok
Thailand Research Site 4 Bangkok
Thailand Research Site 3 Chiang Mai
United Kingdom Research Site 5 Cambridge
United Kingdom Research Site 2 Coventry
United Kingdom Research Site 1 Leicester
United Kingdom Research Site 3 Liverpool
United Kingdom Research Site 6 Newcastle
United Kingdom Research Site 4 Oxford

Sponsors (1)

Lead Sponsor Collaborator
Arrowhead Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Georgia,  Germany,  Korea, Republic of,  New Zealand,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Day 169 up to day 169 (End of Study [EOS])
Secondary Pharmacokinetics (PK) of ARO-C3: Maximum Observed Plasma Concentration (Cmax) up to 48 hours post-dose
Secondary PK of ARO-C3: Area under the Plasma Concentration Versus Time Curve from Zero to 24Hours (AUC0-24) up to 48 hours post-dose
Secondary 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
Secondary 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
Secondary PK of ARO-C3: Terminal Elimination Half-Life (t1/2) up to 48 hours post-dose
Secondary PK of ARO-C3: Apparent Total Body Clearance of ARO-C3 from Plasma (CL) up to 48 hours post-dose
Secondary PK of ARO-C3: Volume of Distribution (Vz/F) up to 48 hours post-dose
Secondary Pharmacodynamics (PD): Change From Baseline in Complement 3 (C3) up to Day 169 Baseline, through Day 169 (EOS)
Secondary PD: Percent Change From Baseline in C3 up to Day 169 Baseline, through Day 169 (EOS)
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