Answer :
In 15 patients with severe congenital ADAMTS-13 deficiency (plasma ADAMTS-13 activity 6%), the safety, tolerability, and pharmacokinetics of recombinant ADAMTS-13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13; BAX 930; SHP655) were examined. This was a prospective phase 1, first-in-human, multicenter dose escalation study.
What is pharmacokinetics?
Pharmacokinetics (PK) is the study of how the body responds to drugs over the full exposure period (medications for the sake of this article). Pharmacodynamics, which closely evaluates the drug's impact on the body, is closely related to this yet clearly distinct from it. Absorption, distribution, metabolism, and excretion are the four primary variables this field often evaluates (ADME). Understanding these processes gives medical professionals the freedom to recommend and deliver drugs that will have the most benefit and the lowest danger, as well as to make adjustments as needed in light of the diverse physiology and lifestyles of their patients.
No significant side effects and no anti-ADAMTS-13 antibodies were found. BAX 930 was well tolerated. Adolescents and adults that received a single dose of BAX 930 at 5, 20, or 40 U/kg body weight showed approximately dose proportional maximum plasma concentration (Cmax [U/mL]) and area under the concentration-time curve (AUC [hU/mL]). Individual ADAMTS-13:Ag and activity levels increased in a dose-related manner and peaked within an hour. A dose-dependent persistence of von Willebrand factor (VWF) cleavage products caused by ADAMTS-13 and a smaller VWF multimeric size were seen with increasing BAX 930 dosages. It was shown in this investigation that BAX 930's pharmacokinetic parameters were similar to those predicted in earlier plasma infusion trials and that pharmacodynamic activity was present.
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