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Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects

Primary Purpose

Cicatrix, Wound Healing

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Avotermin

Placebo

About this trial

This is an interventional prevention trial for Cicatrix focused on measuring Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Clinically healthy, female subjects aged 18-45 years
Weight between 40-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-35 kg/m(squared)). Weight(kg)/height (squared)(m)
Subjects who use appropriate non-pharmaceutical methods of contraception or are not likely to become pregnant for the duration of the trial

Exclusion Criteria:

Subjects who have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied
Subjects with a personal history of a bleeding disorder
Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial
Subjects with any clinically significant medical condition that would impair wound healing including significant rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled digestive heart failure, active malignancy, immunosuppressive, radiation or chemotherapy within the last three months, a history of radiotherapy to the arm or diabetes mellitus
Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial
Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination
Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, HRT, oral contraceptive pill, other pharmaceutical methods of contraception or anticoagulant drugs in the thirty days prior to Day 0
Subjects who have evidence of drug abuse
Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against hepatitis B are not excluded per se
Subjects who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs
Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high risk group and subjects who at any point have a positive pregnancy test
Subjects who are pregnant or become pregnant during the trial
In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason

Sites / Locations

Renovo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intradermal avotermin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.

Secondary Outcome Measures

To assess systemic exposure following intradermal Juvista before and after minor skin incisions.

To assess the anti-scarring potential of intradermal Juvista in a young female population.

Full Information

NCT ID

NCT00984581

First Posted

September 15, 2009

Last Updated

September 24, 2009

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00984581

Brief Title

Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects

Official Title

A Single-site, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and Anti-scarring Potential of Intradermal Juvista in Female Subjects Aged 18-45 Years

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

August 2004 (Actual)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.

Detailed Description

Subjects were to receive two 1cm incisions on the upper, inner aspect of each arm (four wounds per subject). On Day 0 all subjects received intradermal Juvista at a concentration of 50ng/100ul to one incision site on Arm 1 and 5ng/100ul to one incision site on Arm 2. The other incision sites were injected with placebo. Following injection, 1cm incision wounds were made at each site. On Day 1 all subjects were re-injected with 100ul/cm intradermal Juvista or placebo to each side of the wound (200ul per incision) at the same concentration as for Day 0 (50 or 5ng/100ul). At month 6 all incision sites were excised for histological analysis and all excision sites injected with Juvista. Both sites on Arm 1 received 50ng/100ul/linear cm wound margin and both sites on Arm 2 received 5ng/100ul/linear cm wound margin. No excision sites received placebo. The appearance of excision scars was then assessed after 2, 4 and 6 months of healing i.e at months 8, 10 and 12 of the study.

6. Conditions and Keywords

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

Cicatrix, Wound Healing

Keywords

Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intradermal avotermin

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Avotermin

Other Intervention Name(s)

TGFbeta 3, Juvista

Intervention Description

Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6

Intervention Type

Drug

Intervention Name(s)

Avotermin

Other Intervention Name(s)

TGFbeta 3, Juvista

Intervention Description

Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1

Primary Outcome Measure Information:

Title

To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

To assess systemic exposure following intradermal Juvista before and after minor skin incisions.

Time Frame

Month 6

Title

To assess the anti-scarring potential of intradermal Juvista in a young female population.

Time Frame

Month 6-12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically healthy, female subjects aged 18-45 years Weight between 40-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-35 kg/m(squared)). Weight(kg)/height (squared)(m) Subjects who use appropriate non-pharmaceutical methods of contraception or are not likely to become pregnant for the duration of the trial Exclusion Criteria: Subjects who have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied Subjects with a personal history of a bleeding disorder Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial Subjects with any clinically significant medical condition that would impair wound healing including significant rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled digestive heart failure, active malignancy, immunosuppressive, radiation or chemotherapy within the last three months, a history of radiotherapy to the arm or diabetes mellitus Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, HRT, oral contraceptive pill, other pharmaceutical methods of contraception or anticoagulant drugs in the thirty days prior to Day 0 Subjects who have evidence of drug abuse Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against hepatitis B are not excluded per se Subjects who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high risk group and subjects who at any point have a positive pregnancy test Subjects who are pregnant or become pregnant during the trial In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Duncan

Organizational Affiliation

Renovo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeremy Bond

Organizational Affiliation

Renovo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renovo

City

Manchester

ZIP/Postal Code

M13 9XX

Country

United Kingdom

12. IPD Sharing Statement

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Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects

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