Cicatrix, Hypertrophic Clinical Trial
Official title:
A Phase 1, Single Center, Placebo-controlled, Interventional Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles in Healthy Subjects Compared to Placebo
The Study Drug is an investigational drug which is being developed by OliX Pharmaceuticals
Inc., with an aim to help people who develop hypertrophic scars (a type of permanent scar) in
the future. Hypertrophic scars are formed when a wound becomes red, raised, and itchy before
it eventually heals. These scars tend to develop due to disease, surgical operations, or
burns. Available physical treatment methods to remove scars include surgery or laser therapy;
however these are often accompanied by further complications including pain and recurrence of
the scar and can be costly. Similarly, therapeutic agents such as ointments or oral drugs
have little to no effect in preventing or treating hypertrophic scars. The aims of this Study
are to determine the safety of the Study Drug and any side effects that might be associated
with it, and how much of the Study Drug gets into the bloodstream and how long it takes the
body to remove it.
The healthy adult subjects can participate in this study in the age between 18 and 60 years
old in the UK.
This study will be conducted in 2 parts, Part A and B. Part A will be a single subcutaneous
or intradermal dose, dummy controlled study. Part B will be a multiple intradermal dose,
dummy controlled study.
The aims of this Study are to determine the safety of the Study Drug and any side effects
that might be associated with it, and how much of the Study Drug gets into the bloodstream
and how long it takes the body to remove it.
As the selection criteria for the subjects, the healthy adult subjects can participate in
this study in the age between 18 and 60 years old in the UK. Both female and male subjects
can participate in this study.
This study will be conducted in 2 parts, Part A and B. Part A will be a single subcutaneous
dose (Groups A1 to A4) or intradermal dose (Groups A5 to A8), dummy controlled study.
Overall, 32 subjects will be studied in 8 groups; 4 groups (Groups A1 to A4) of 4 subjects to
assess OLX10010 administered subcutaneously and 4 groups (Groups A5 to A8) of 4 subjects to
assess OLX10010 administered intradermally.
Part B will be a multiple intradermal dose, dummy controlled study. Overall, 12 subjects will
be studied as 3 groups (Groups B1 to B3) with each group consisting of 4 subjects. In each
group, 3 subjects will receive OLX10010 and 1 subject will receive placebo.
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