Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.
This is a multi-center, randomized, double-blind, placebo-controlled, single ascending dose phase Ib study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible subjects will undergo screening assessments and PRS-080#22-DP will be administered by intravenous infusion. The study will consist of 3 dose cohorts of 2 mg/kg, 4 mg/kg, and 8 mg/kg body weight with 8 subjects in each cohort. Using a standard 6+2 design, 6 subjects in each cohort will be randomized to PRS-080#022-DP and 2 subjects in each cohort will be randomized to placebo. The decision to escalate the dose will be based on an interim analysis of clinical safety and safety laboratory data. Safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Hepcidin antagonism to mobilize iron and to treat anemia
Placebo comparator
St. Joseph Krankenhaus
Berlin, Germany
Technical University, Medical Department
Munich, Germany
Number of patients with adverse events
Composite measure including signs and symptoms, changes from baseline heart rate and blood pressure, ECG, body temperature, respiratory rate clinical chemistry and hematology
Time frame: 28 days
Pharmacokinetics of PRS-080#022
Area under the plasma concentration versus time curve (AUC) of PRS-080 in plasma
Time frame: 28 days
Effects of PRS-080#022 on serum iron
Changes in total serum iron concentration compared to baseline
Time frame: 28 days
Effects of PRS-080#022 on ferritin
Changes in serum ferritin concentration compared to baseline
Time frame: 28 days
Effects of PRS-080#022 on transferrin saturation
Changes in serum transferrin saturation compared to baseline
Time frame: 28 days
Effect of PRS-080#022 on hepcidin concentrations in plasma
Changes in hepcidin concentration compared to baseline
Time frame: 28 days
Number of patients developing anti-drug antibodies
Number of patients with antibodies against PRS-080#022 at day 28 compared to baseline.
Time frame: 28 days
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