Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03569267
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2018-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and PK Profiles of OLX10010 in Healthy Subjects
Sponsor:
Olix Pharmaceuticals, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: