A Study to Evaluate Safety and PK Profiles of OLX10010 in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT03569267|
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : August 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cicatrix, Hypertrophic||Drug: OLX10010 Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||May 21, 2018|
|Actual Primary Completion Date :||June 27, 2019|
|Actual Study Completion Date :||June 27, 2019|
OLX10010, an siRNA therapeutic, with four different doses by Groups (dose ascending manner with 1, 4, 10, 20 mg)
A cell penetrating asymmetric siRNA (cp asiRNA)
Placebo Comparator: Placebo
- Number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Day 14 (single dose) ]Incidence and severity of adverse events; vital sign measurements; 12-lead electrocardiogram (ECG) parameters; incidence of clinical laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results; analysis of coagulation parameters; physical examinations; local tolerability assessments of subcutaneous and intradermal injection sites
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569267
|Covance Clinical Research Unit (CRU) Ltd.|
|Leeds, United Kingdom, LS2 9LH|
|Principal Investigator:||Jim Bush, Dr.||Covance Clinical Research Unit|