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A Study to Evaluate Safety and PK Profiles of OLX10010 in Healthy Subjects

NCT03569267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-08-08

No results posted yet for this study

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.

Conditions

  • Cicatrix, Hypertrophic

Interventions

DRUG

OLX10010

A cell penetrating asymmetric siRNA (cp asiRNA)

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Olix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jim Bush, Dr. · Covance Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2019-06-27
Completion
2019-06-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569267 on ClinicalTrials.gov