This is a randomised, double-blind, placebo-controlled multiple ascending single study. It is hypothesised that at least dose of DS-1093a will be safe and tolerable over a 2-week treatment period and will result in increases in reticulocyte count and haemoglobin concentrations in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
31
Hammersmith Medicines Research Ltd
London, United Kingdom
blood concentration of DS-1093
level of DS-1093 will be determined in participants blood from the time of initial dosing through 15 days after.
Time frame: time of dosing through Day 15
number of adverse events including type and severity
number, type and severity of adverse events will be reported during the study from initial randomization through Day 98
Time frame: date of randomization through Day 98
levels of EPO
Pharmacodynamic (PD) analyses will be conducted for EPO (Erythropoietin ) through 42 days after initial dosing
Time frame: time of dosing through 42 days after dosing
levels of VEGF
Pharmacodynamic (PD) analyses will be conducted forVEGF (Vascular Endothelial Growth Factor) through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of H25
Pharmacodynamic (PD) analyses will be conducted for H25 (Hepcidin-25); through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of Reticulocytes
Pharmacodynamic (PD) analyses will be conducted for hematology markers {RET (Reticulocytes), through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of Haemoglobin
Pharmacodynamic (PD) analyses will be conducted for hematology markers Hb (haemoglobin), through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
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levels of Haematocrit
Pharmacodynamic (PD) analyses will be conducted for hematology markers HCT (haematocrit), through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of Red Blood Cells
Pharmacodynamic (PD) analyses will be conducted for hematology marker RBC (red blood cells) through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of Serum Iron
Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker {SI (Serum Iron) through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of Transferrin
Pharmacodynamic (PD) analyses will be conducted for iron metabolism markers T (Transferrin), through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of TSAT
Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker TSAT(Saturated Transferrin) through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing
levels of Ferrin
Pharmacodynamic (PD) analyses will be conducted for iron metabolism marker F (Ferritin) through 42 days of dosing.
Time frame: time of dosing through 42 days after dosing