NL-OMON42731
Withdrawn
Not Applicable
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. - BN201 SAD MAD study
Bionure Pharma S.L. Barcelona0 sites32 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- inflammation of the optic nerve.
- Sponsor
- Bionure Pharma S.L. Barcelona
- Enrollment
- 32
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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