The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of single and multiple doses of BN201 in healthy subjects.
This is a phase I, randomised, double-blind, placebo-controlled study to assess the safety,
tolerability, pharmacokinetics and pharmacodynamics of BN201 in healthy subjects following
single ascending doses and two cohorts of multiple doses. The study will be conducted in two
parts (Part A and Part B). Part A (up to 8 single ascending doses (SD)) will be conducted in
32 subjects (4 interlocking cohorts of 8 subjects). Part B (up to 2 multiple ascending doses
(MD)) will be conducted in 16 subjects (2 cohorts of 8 subjects). Subjects in Part A will
undergo a screening period (Day -28 to Day -2), two in-patient treatment periods compromising
3 overnight stays (from Day -1 to Day 3) with a wash out period of at least 14 days between
dose administrations and a follow up visit 12 to 16 days following administration of IMP.
Subjects in Part B will undergo a screening period (Day -28 to Day -2), an in-patient
treatment period compromising 7 overnight stays (from Day -1 to Day 7) and a follow up visit
12 to 16 days following final administration of Investigational Medicinal Product (IMP).