A phase 1 study of DCR-PH1 in patients with primary hyperoxaluria type 1 (PH1) to determine the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics (PD) effects of DCR-PH1 administered via-intravenous infusion (IV)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Unnamed facility
Bonn, Germany
Unnamed facility
Amsterdam, Netherlands
The safety of DCR-PH1 evaluated by the proportion of subjects that experience adverse events (AEs)
Time frame: Through Day 29
Profile of pharmacokinetics (PK) of DCR-PH1 - Cmax
Time frame: Through Day 29
Profile of pharmacokinetics (PK) of DCR-PH1 - tmax
Time frame: Through Day 29
Profile of pharmacokinetics (PK) of DCR-PH1 - AUC
Time frame: Through Day 29
Profile of pharmacokinetics (PK) of DCR-PH1 - t½
Time frame: Through Day 29
The effect of DCR-PH1 on plasma glycolate levels
Time frame: Through Day 29
The effect of DCR-PH1 on urine glycolate levels
Time frame: Through Day 29
The effect of DCR-PH1 on plasma oxalate levels
Time frame: Through Day 29
The effect of DCR-PH1 on urine oxalate levels
Time frame: Through Day 29
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