RATIONALE FOR DOSE SELECTION Sample Clauses

RATIONALE FOR DOSE SELECTION. 5.2.1 Initial dose (see Appendix A) Data from in vitro experiments investigating the binding kinetics of NI-0501 to human IFNγ and the functional inhibition of human IFNγ by NI-0501 have been used for predicting the concentrations of NI- 0501 expected to inhibit (e.g. 99%) the effect of circulating IFNγ concentrations. Based on: • the calculated neutralizing concentrations of NI-0501 • the PK parameters of NI-0501 in healthy volunteers • the PK information from recombinant IFNγ in humans, simulations were performed regarding the dose that would inhibit the effect of circulating and newly formed IFNγ by up to 99% over a period of 3 days in HLH patients. Based on these simulations, the starting dose in HLH patients is 1 mg/kg. This dose is predicted to inhibit for 3 days at least 99% of IFNγ effect in patients with baseline IFNγ concentrations lower or equal to 3400 pg/mL. This dose is mainly driven by the estimated production of IFNγ which is expected to impact the clearance of NI-0501 (due to target-mediated drug disposition) and varies considerably between patients as already indicated by the wide range of baseline IFNγ concentrations observed in these patients.
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Related to RATIONALE FOR DOSE SELECTION

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