My idea only, I have seldom translated clinical studies, although I did a few.

The trial was a first human dose trial designed as an open-label dose escalation trial with the purpose of evaluating safety and pharmacokinetic properties of three ascending doses of N9-GP in hemophilia B patients in a non-bleeding state. The doses were 25 U/kg, 50 U/kg and 100 U/kg. Five patients were to complete each of the three dose cohorts. The trial consisted of five visits in total (Figure 1). At the first dosing visit (Visit 2) the patient received a single dose of their previous FIX product (pdFIX or rFIX) at the same dose level as the N9-GP dose that was to be administered at the following visit (Visit 3). A wash-out period of seven days
was required before dosing at Visit 2 and 3. If patients received FIX treatment within these
seven days, the visit was postponed accordingly. There was also a seven days wash-out period
prior to the antibody assessment at Visit 5 in order to avoid the interference of FIX activity on
the antibody assays.

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