Document Classification

Section Type: METHODS

Text: The clinical trial was comprised of the following four studies : (i) an open-label, single-dose escalation study to evaluate the safety and tolerability in healthy subjects after intranasal doses of BCQB ranging from 45 to 450g (total of six doses) ; (ii) an open-label, multiple-dose escalation study to assess the safety and tolerability in healthy subjects after intranasal administration with 120 and 150g doses of BCQB (360 and 450g/day) administered three times daily for 15 days ; (iii) a randomized, open-label and parallel-group design to evaluate the single-dose pharmacokinetics of BCQB after intranasal dosing (45, 90, and 180g) ; and (iv) ten subjects received 120g of BCQB by intranasal administration, three times daily for 5 days with a final single dose on day 7 to assess its multiple-dose pharmacokinetics.