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Table 1 Study schema for single-dose and multiple-dose escalation stagesa

From: Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial

Stage dose and route Patients, n(active:placebo)
SAD stage dose, route (cohort)  
   0.3 IV (A) 4:1
   1.0 IV (B) 4:1
   1.0 SC (C) 4:1
   3.0 IV (D) 4:1
   3.0 SC (E) 4:1
   5.0 IV (F) 4:1
MAD stage dose, route (cohort)  
   1.0 SC (G) 8:2
   3.0 SC (H) 16:4
   5.0 IV (I) 4:1
  1. aIV = intravenously; MAD = multiple ascending doses; SAD = single ascending dose; SC = subcutaneously.