Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
ID
Source
Brief title
Condition
- Eye disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of adverse events (AEs).
Secondary outcome
Changes in ophthalmological examinations (i.e. visual acuity, slit lamp exam,
corneal sensitivity testing, and fluorescence tear film break-up time);
Tolerability scores (Ocular Comfort Index (OCI) and Visual Analogue Scale
(VAS)).
Background summary
Ocular side effects have emerged as an important clinical concern for
molecularly targeted cancer therapies, despite these targeting therapies being
more tumor selective than traditional systemic cytotoxic chemotherapy. In some
cases these ocular side effects can be attributed to on-target effects due to
target antigen expression in the eye, but, alternatively, toxicities may occur
via off-target mechanisms and the etiology of such events is less clearly
defined.
Byondis has developed a new-generation platform of linker-drugs (LD) in which
the payload is based on chemically synthesized duocarmycins which are
DNA-alkylating cytotoxic drugs [5] which induce cell death in both dividing and
nondividing cells.
Byondis* aim is to improve the therapeutic index with ADCs based on these new
LDs as compared to earlier generation ADCs. The first LD from this platform is
valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA)
which is coded as SYD980. Currently three ADCs using this LD are in clinical
investigation.
See the IB for further information.
Study objective
Primary objective:
* To evaluate the safety of BYON5667 eye drops.
Secondary objective:
* To evaluate the tolerability of BYON5667 eye drops.
Study design
This is a single center, randomized, placebo-controlled, double-blind study in
healthy subjects.
Intervention
BYON5667 or placebo eye drops
Study burden and risks
Since the study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IB for further
information.
Microweg 22
Nijmegen 6545 CM
NL
Microweg 22
Nijmegen 6545 CM
NL
Listed location countries
Age
Inclusion criteria
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 ).
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-005574-10-NL |
| CCMO | NL76698.056.21 |