Lead Sponsor

Novo Nordisk A/S

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

No

•Capable and willing to provide written informed consent or assent
•Documented diagnosis of PH1 or PH2, confirmed by genotyping
•Must meet the 24 hour urine oxalate excretion requirements
•Less than 20% variation between the two 24-hour urinary creatinine excretion values derived from the two 24-hour urine collections in the screening period
•Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m2 BSA

•Renal or hepatic transplantation (prior or planned within the study period)
•Currently on dialysis or anticipated requirement for dialysis during the study period
•Plasma oxalate \>30 µmol/L
•Documented evidence of clinical manifestations of systemic oxalosis (including pre-existing retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)
•Use of an RNA interference (RNAi) drug within the last 6 months
•Participation in any clinical study in which you received an investigational medicinal product (IMP) within 4 months before Screening
•Liver function test (LFT) abnormalities: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 times upper limit of normal (ULN) for age and gender
•Inability or unwillingness to comply with study procedures

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