A study in healthy volunteers to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of BN201, an investigational compound for the treatment of acute optic neuritis.
- Conditions
- inflammation of the optic nerve.10030061
- Registration Number
- NL-OMON42731
- Lead Sponsor
- Bionure Pharma S.L. Barcelona
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 32
- 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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety : In both study parts: adverse events (AEs; including infusion site<br /><br>reactions), clinical laboratory, vital signs, 12 lead electrocardiogram (ECG),<br /><br>telemetry and physical examination<br /><br>In Part A only: Holter monitoring and electroencephalogram (EEG)<br /><br>In Part B only: Columbia-Suicide Severity Rating Scale (C-SSRS)<br /><br>questionnaire, quantitative sensory testing (QST) for mechano-sensitivity, and<br /><br>visual analog scale (VAS) for spontaneous pain<br /><br>PK : Plasma BN201 concentrations<br /><br>Plasma PK parameters estimated using noncompartmental analysis, as<br /><br>appropriate: Cmax, tmax, kel, t1/2, AUC0-t, AUC0-24, AUC0-inf, %AUCextra, CL,<br /><br>Vz and dose linearity (Parts A and B), and Ctrough and Rac (Part B only)<br /><br>PD : Translocation of Foxo3 from nucleus to cytoplasm in peripheral blood<br /><br>mononuclear cells (PBMCs)</p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a </p><br>