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

Primary Purpose

Cicatrix, Hypertrophic

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

OLX10010

Placebo

About this trial

This is an interventional treatment trial for Cicatrix, Hypertrophic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening.
In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia [eg, Gilbert's syndrome] is not acceptable) at Screening and/or Check in as assessed by the Investigator (or designee).
Female subjects will be non pregnant and non lactating.
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a male barrier method of contraception (ie, a male condom with spermicide) in addition to a second method of acceptable contraception used by their female partners or to refrain from donating sperm from Check in until 90 days after the Follow up Visit .
Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (ie, a male condom with spermicide) or to refrain from donating ova from the time of signing the ICF until 90 days after the Follow up Visit.
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
Subjects with serum creatinine >ULN.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
Alcohol consumption of >28 units per week for males and >21 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1⁄6 gill (25 mL) of spirits.
Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening and/or Check in.
Positive hepatitis panel and/or positive human immunodeficiency test at Screening. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months (or 5 half lives, whichever is longer) prior to Check in.

Sites / Locations

Covance Clinical Research Unit (CRU) Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OLX10010

Placebo

Arm Description

OLX10010, an siRNA therapeutic, with four different doses by Groups (dose ascending manner with 1, 4, 10, 20 mg)

placebo

Outcomes

Primary Outcome Measures

Number of subjects with treatment-related adverse events as assessed by CTCAE v4.0

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03569267

First Posted

May 20, 2018

Last Updated

August 7, 2019

Sponsor

Olix Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03569267

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

May 21, 2018 (Actual)

Primary Completion Date

June 27, 2019 (Actual)

Study Completion Date

June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Olix Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cicatrix, Hypertrophic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OLX10010

Arm Type

Experimental

Arm Description

OLX10010, an siRNA therapeutic, with four different doses by Groups (dose ascending manner with 1, 4, 10, 20 mg)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

OLX10010

Intervention Description

A cell penetrating asymmetric siRNA (cp asiRNA)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Number of subjects with treatment-related adverse events as assessed by CTCAE v4.0

Description

Time Frame

Day 14 (single dose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia [eg, Gilbert's syndrome] is not acceptable) at Screening and/or Check in as assessed by the Investigator (or designee). Female subjects will be non pregnant and non lactating. Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Exclusion Criteria: Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a male barrier method of contraception (ie, a male condom with spermicide) in addition to a second method of acceptable contraception used by their female partners or to refrain from donating sperm from Check in until 90 days after the Follow up Visit . Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (ie, a male condom with spermicide) or to refrain from donating ova from the time of signing the ICF until 90 days after the Follow up Visit. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). Subjects with serum creatinine >ULN. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). History of alcoholism or drug/chemical abuse within 2 years prior to Check in. Alcohol consumption of >28 units per week for males and >21 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1⁄6 gill (25 mL) of spirits. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening and/or Check in. Positive hepatitis panel and/or positive human immunodeficiency test at Screening. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months (or 5 half lives, whichever is longer) prior to Check in.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jim Bush, Dr.

Organizational Affiliation

Covance Clinical Research Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Covance Clinical Research Unit (CRU) Ltd.

City

Leeds

ZIP/Postal Code

LS2 9LH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Ethics Review Panel. Requestors will be required to sign a Data Access Agreement.

Learn more about this trial

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

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