A Phase 1 Study to Evaluate the Safety and Tolerability of BYON5667 Eye Drops in Healthy Subjects
- Conditions
- ocular side effects with ADCs10015919
- Registration Number
- NL-OMON50780
- Lead Sponsor
- Byondis B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Healthy male and female subjects, aged from 18 to 75 years at the time of
signing informed consent.
Presence of two functional eyes.
Good physical and mental health.
Female subjects of childbearing potential: an acceptable effective method of
contraception must be used during the trial until the end-of-study (EOS ).
Presence or history of ocular disease or ocular trauma, or history of ocular
surgery including laser-therapy, or ocular signs or symptoms of systemic
disease , including current or prior pathology of eyelid or tear duct .
Amblyopia and color blindness are allowed.
Recent (within 2 months prior to signing informed consent) or current use of
eye drops, or other (systemic) medication that may affect the eye according to
the summary of product characteristics.
Use of contact lenses within 14 days before Day 1 and for the duration of the
study.
Known active microbial, fungal or viral infection if deemed clinically
significant by the investigator.
Subject is pregnant or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method