Key result
A single subcutaneous administration of ALXN4100TPO (1-100 mg/kg) in CD2F1 mice increased platelet counts and hematopoietic tissue changes without life-threatening adverse events.
Why the study?
Does ALXN4100TPO cause toxicity or alter pharmacokinetics and pharmacodynamics in CD2F1 mice?
Population
CD2F1 mice
Comparison
Single subcutaneous administration of ALXN4100TPO vs Naïve mice and control antibody
Design
Preclinical, randomized into naïve, control antibody, low, medium, or high…
Authors
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Supports further preclinical development; leaves open human safety, efficacy, and translation.
Does ALXN4100TPO cause toxicity or alter pharmacokinetics and pharmacodynamics in CD2F1 mice?
ALXN4100TPO demonstrates a favorable safety profile and expected pharmacodynamic effects (increased platelets) in a murine model.
Satyamitra et al. (2013) studied this question. ALXN4100TPO vs. naïve, control antibody (ALXN4200, 100 mg/kg) was evaluated on clinical observations, body weight changes, hematology, histopathology, pharmacokinetics, pharmacodynamics. A single subcutaneous administration of ALXN4100TPO (1-100 mg/kg) in CD2F1 mice increased platelet counts and hematopoietic tissue changes without life-threatening adverse events.
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