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 treatment of anemia of chronic disease. This phase I First-in-Human study shall investigate safety and pharmacokinetics in healthy human volunteers.
First-in-Human (FIH), randomized, dose-escalation, double-blind, placebo-controlled single dose in healthy volunteers. The single rising dose study will enroll 8 subjects per cohort (6 verum, 2 placebo), up to a maximum tolerated dose, defined by stopping rules. 6 dose levels are anticipated. Study drug will be administered as i.v. infusion on Day 1. The decision to escalate the dose by the dose escalation committee (DEC) will be based on an interim analysis of clinical safety and safety laboratory data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
48
hepcidin antagonist
Placebo treatment
Nuvisan GmbH
Neu-Ulm, Germany
Number of subjects with adverse events
Composite measure including signs and symptoms, local reactions, changes from baseline heart rate and blood pressure, ECG, body temperature, respiratory rate, clinical chemistry and hematology, coagulation and urinalysis over a 28 day period
Time frame: up to 28 days
Pharmacokinetics of PRS-080#22-DP following administration of single doses
Area under the plasma concentration versus time curve (AUC) of PRS-080#22-DP in blood
Time frame: 14 time points up to 11 days
Assessment of anti-drug antibodies in blood following single administration
Analysis of antibodies against PRS-080#22-DP at day 28 compared to baseline
Time frame: up to 28 days
Effect of PRS-080#22-DP on hepcidin concentrations in blood
Changes in hepcidin concentration compared to baseline
Time frame: 15 time points up to 28 days
Effect of PRS-080#22-DP on total iron
Changes in total iron concentration in blood compared to baseline
Time frame: up to 28 days
Effect of PRS-080#22-DP on transferrin saturation
Changes in transferrin saturation in blood compared to baseline
Time frame: up to 28 days
Effect of PRS-080#22-DP on ferritin
Changes to ferritin concentration in blood compared to baseline
Time frame: up to 28 days
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