A double blind, randomized, cross-over, placebo controlled study, evaluating the time-to-onset of action of BLX000441-002 nasal spray in healthy volunteers.

INTERVENTION: Product Name: Cetirizine dinitrate Product Code: BLX000441‐002 Pharmaceutical Form: Nasal spray* INN or Proposed INN: cetirizine dinitrate Current Sponsor code: BLX000441‐002 Other descriptive name: (RS)‐2‐{2‐[4‐[(4‐Chloro‐phenyl)‐phenylmethyl]‐piperazin‐1‐yl]‐ethoxy}‐acetic acid dinitrate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 10.54‐11.66 Pharmaceutical form of the placebo: Nasal spray* Route of administration of the placebo: Nasal use CONDITION: healthy volunteers PRIMARY OUTCOME: Main Objective: BLX000441‐002 is intended for the treatment of seasonal allergic rhinitis.; ; The primary objective in this study is to evaluate the time‐to‐onset of action of BLX000441‐002 nasal spray compared with placebo, as measured by alfa2‐macroglobulin levels, after a single dose in healthy volunteers; Primary end point(s): Alfa2‐macroglobulin is used as a measure of the amount of plasma exudation after, in this study, a histamine challenge Secondary Objective: The secondary objectives are:; ‐ to evaluate the Total Nasal Symptom Score of BLX000441‐002 nasal spray compared with placebo after a single dose in healthy volunteers; ‐ to evaluate the safety of BLX000441‐002 nasal spray; INCLUSION CRITERIA: 1. Written informed consent to participate in the study obtained 2. Male or female subject aged 18‐50 years, extremes included 3. Body Mass Index between 18 and 28 kg/m2 , extremes included 4. Good age‐related health condition as judged by the investigator and established by medical history and physical examination at the screening visit. 5. Negative skin prick test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range