inflammation of the optic nerve.
Conditions
Interventions
Part 1:
During the study you will receive BN201 or placebo after an overnight fast (at
least 10 hours no eating and drinking) as an iv infusion. The duration of the
iv infusion will be approximately
Sponsors
Bionure Pharma S.L. Barcelona
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - healthy male or female - 18-55 years old inclusive - BMI between 18.0 - 32 kg/m2 - smokes less than 6 cigarettes per day (or 1 cigar or pipe)
Exclusion criteria
Exclusion criteria: strenuous activity (e.g. sports) is not allowed from 96 hours (4 days) prior to entry into the clinical research center and during your stay in the clinical research center. you are not allowed to eat or drink (fast) from 4 hours prior to the pre-study screening, from 4 hours prior to entry into the clinical research center and from 4 hours prior to the poststudy screening .you are not allowed to consume any methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, *powerdrinks*) or alcohol, from 48 hours (2 days) prior to entry into the clinical research center and during your stay in the clinical research center. you are not allowed to consume any foods containing poppy seeds from 48 hours (2 days) prior to the prestudy screening and entry into the clinical research center as this could cause a false-positive drug screen result. you are not allowed to use any prescribed medication during 30 days prior to entry into the clinical research center until the poststudy screening .you are not allowed to use any over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g. St. John*s Wort), from 14 days prior to entry into the clinical research center until the poststudy screening. you are not allowed to have had a serious infection (e.g., pneumonia) within 2 months before the pre-study screening. you are not allowed to have had an active bacterial or viral infection and fever (body temperature >38°C) within 48 hours (2 days) prior to the first administration of the study compound.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety : In both study parts: adverse events (AEs; including infusion site reactions), clinical laboratory, vital signs, 12 lead electrocardiogram (ECG), telemetry and physical examination In Part A only: Holter monitoring and electroencephalogram (EEG) In Part B only: Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire, quantitative sensory testing (QST) for mechano-sensitivity, and visual analog scale (VAS) for spontaneous pain PK : Plasma BN201 concentrations Plasma PK parameters estimated using noncompartmental analysis, as appropriate: Cmax, tmax, kel, t1/2, AUC0-t, AUC0-24, AUC0-inf, %AUCextra, CL, Vz and dose linearity (Parts A and B), and Ctrough and Rac (Part B only) PD : Translocation of Foxo3 from nucleus to cytoplasm in peripheral blood mononuclear cells (PBMCs) | — |
Countries
Netherlands
Outcome results
None listed