Phase
Condition
Nephropathy
Kidney Disease
Glomerulonephritis
Treatment
ARO-C3
Placebo
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Connect with a study center
Research Site 1
Camperdown, New South Wales 2050
AustraliaSite Not Available
Research Site 3
Concord, New South Wales 2139
AustraliaSite Not Available
Research Site 1
Camperdown 2172563, New South Wales 2155400 2050
AustraliaSite Not Available
Research Site 3
Concord 2170852, New South Wales 2155400 2139
AustraliaSite Not Available
Research Site 2
Clayton, Victoria 3168
AustraliaSite Not Available
Research Site 2
Clayton 2171400, Victoria 2145234 3168
AustraliaSite Not Available
Research Site 1
Tbilisi, 0159
GeorgiaSite Not Available
Research Site 2
Tbilisi, 0112
GeorgiaSite Not Available
Research Site 3
Tbilisi, 0186
GeorgiaSite Not Available
Research Site 2
Tbilisi 611717, 0112
GeorgiaSite Not Available
Research Site 2
Cologne, 50937
GermanySite Not Available
Research Site 2
Cologne 2886242, 50937
GermanySite Not Available
Research Site 4
Erlangen, 91054
GermanySite Not Available
Research Site 4
Erlangen 2929567, 91054
GermanySite Not Available
Research Site 3
Halle, 06120
GermanySite Not Available
Research Site 1
Mainz, 55131
GermanySite Not Available
Research Site 1
Gamcheon, Busan 49267
Korea, Republic ofSite Not Available
Research Site 2
Haeundae, Busan 48108
Korea, Republic ofSite Not Available
Research Site 4
Goyang-si, Gyeonggi-do 10444
Korea, Republic ofSite Not Available
Research Site 5
Seongnam, Gyeonggi-do 13496
Korea, Republic ofSite Not Available
Research Site 1
Busan, 49267
Korea, Republic ofSite Not Available
Research Site 2
Busan, 48108
Korea, Republic ofSite Not Available
Research Site 4
Busan, 48108
Korea, Republic ofSite Not Available
Research Site 3
Daegu, 42601
Korea, Republic ofSite Not Available
Research Site 4
Goyang, 10444
Korea, Republic ofSite Not Available
Research Site 9
Gyeonggi-do, 10444
Korea, Republic ofSite Not Available
Research Site 8
Incheon, 21565
Korea, Republic ofSite Not Available
Research Site 9
Seoul, 6591
Korea, Republic ofSite Not Available
Research Site 5
Soeul, 5505
Korea, Republic ofSite Not Available
Research Site 6
Soeul, 03722
Korea, Republic ofSite Not Available
Research Site 7
Soeul, 08308
Korea, Republic ofSite Not Available
Research Site 8
Soeul, 05030
Korea, Republic ofSite Not Available
Research Site
Auckland, 1010
New ZealandSite Not Available
Research Site
Auckland 2193733, 1010
New ZealandSite Not Available
Research Site 1
Gamcheon, Busan 1838519 49267
South KoreaSite Not Available
Research Site 2
Haeundae 1844708, Busan 1838519 48108
South KoreaSite Not Available
Research Site 3
Daegu 1835329, Daegu 1835327 42601
South KoreaSite Not Available
Research Site 4
Goyang-si 1842485, Gyeonggi-do 1841610 10444
South KoreaSite Not Available
Research Site 6
Soeul 6808867, 03722
South KoreaSite Not Available
Research Site 8
Soeul 6808867, 05030
South KoreaSite Not Available
Research Site 1
Barcelona, 08003
SpainSite Not Available
Research Site 2
Barcelona, 08035
SpainSite Not Available
Research Site 3
Madrid, 28015
SpainSite Not Available
Research Site 1
Bangkok, 10330
ThailandSite Not Available
Research Site 2
Bangkok, 10400
ThailandSite Not Available
Research Site 4
Bangkok, 10700
ThailandSite Not Available
Research Site 2
Bangkok 1609350, 10400
ThailandSite Not Available
Research Site 3
Chiang Mai, 50200
ThailandSite Not Available
Research Site 3
Chiang Mai 1153671, 50200
ThailandSite Not Available
Research Site 6
Hat Yai, 90110
ThailandSite Not Available
Research Site 5
Cambridge, CB20QQ
United KingdomSite Not Available
Research Site 2
Coventry, CV2 2DX
United KingdomSite Not Available
Research Site 1
Leicester, LE1 SWW
United KingdomSite Not Available
Research Site 3
Liverpool, L7 8YE
United KingdomSite Not Available
Research Site 6
Newcastle, NE7 7DN
United KingdomSite Not Available
Research Site 4
Oxford, OX3 7LE
United KingdomSite Not Available
Research Site 4
Oxford 2640729, OX3 7LE
United KingdomSite Not Available

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