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Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects

Primary Purpose

Cicatrix

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Avotermin (RN1001)

About this trial

This is an interventional basic science trial for Cicatrix

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy, non-Afro-Caribbean, male subjects aged 18-45 years inclusive.
Weight between 60 and 150kg and a body mass index between 15 - 55 kg/m2.
Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation

Exclusion Criteria:

Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring.
Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
Subjects with tattoos or previous scars in the areas to be biopsied.
Subjects, who on direct questioning and physical examination, have evidence of any past or present clinically significant disease and particularly coagulation disorders, immuno mediated conditions and skin diseases and allergies, such as eczema.
Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study.
Subjects with any clinically significant abnormality following review of pre study laboratory data and full physical examination.
Subjects who are taking, or have taken, certain prescribed or investigational drug in the three weeks prior to Day 0 and in particular topical or systemic steroids, and anti-coagulant drugs. Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements, inhaled salbutamol, thyroxine replacement therapy, OTC cold remedies.
Subjects who drink more than 28 units of alcohol per week (1 unit = ½ pint of beer (285mls) or 25ml of spirits or 1 glass of wine).
Subjects who have current 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 known to have or had serum hepatitis or 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.
In the opinion of the investigator, a subject who is not likely to complete the study for what ever reason.

Sites / Locations

Renovo CTU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Other

Arm Label

Arm Description

50ng Avotermin/100ul

20ng Avotermin/100ul

5ng Avotermin/100ul

100ng Avotermin/100ul

500ng Avotermin/100ul

0.25ng Avotermin/100ul

1ng Avotermin/100ul

20ng Avotermin/100ul

50ng Avotermin/100ul

Outcomes

Primary Outcome Measures

Scar severity

Secondary Outcome Measures

Treatment local and systemic tolerance

Full Information

NCT ID

NCT00847925

First Posted

February 17, 2009

Last Updated

February 18, 2009

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00847925

Brief Title

Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects

Official Title

A Double Blind, Placebo and Standard Care Controlled, Randomised Study to Investigate the Clinical Safety and Toleration, Wound Healing and Antiscarring Potential of Two Applications of Intradermal RN1001 (Avotermin) in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

November 2001 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects

Detailed Description

Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject served as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing and subsequent scarring. Subjects were initially dosed and wounded (incisions and punch biopsies) on Day 0 and re-dosed on Day 1. On Day 3, Arm 1 incisions and punch biopsies were re-dosed as per Day 0 and excised, and re-dosed again on Day 4. Arm 2 punch biopsies were excised at Day 5 but not re-dosed. Healed incisions/scars on Arm 2 were excised for histological analysis after 12 months and not re-dosed. All subjects, regardless of treatment were treated according to best practices for moist wound healing.

6. Conditions and Keywords

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

Cicatrix

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

50ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

20ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

5ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

100ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

500ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

0.25ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

1ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

20ng Avotermin/100ul

Arm Title

Arm Type

Other

Arm Description

50ng Avotermin/100ul

Intervention Type

Drug

Intervention Name(s)

Avotermin (RN1001)

Intervention Description

100ul/linear cm of wound. Dosed before surgery and 24h later

Primary Outcome Measure Information:

Title

Scar severity

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Treatment local and systemic tolerance

Time Frame

12 Months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy, non-Afro-Caribbean, male subjects aged 18-45 years inclusive. Weight between 60 and 150kg and a body mass index between 15 - 55 kg/m2. Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation Exclusion Criteria: Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring. Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring. Subjects with tattoos or previous scars in the areas to be biopsied. Subjects, who on direct questioning and physical examination, have evidence of any past or present clinically significant disease and particularly coagulation disorders, immuno mediated conditions and skin diseases and allergies, such as eczema. Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study. Subjects with any clinically significant abnormality following review of pre study laboratory data and full physical examination. Subjects who are taking, or have taken, certain prescribed or investigational drug in the three weeks prior to Day 0 and in particular topical or systemic steroids, and anti-coagulant drugs. Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements, inhaled salbutamol, thyroxine replacement therapy, OTC cold remedies. Subjects who drink more than 28 units of alcohol per week (1 unit = ½ pint of beer (285mls) or 25ml of spirits or 1 glass of wine). Subjects who have current 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 known to have or had serum hepatitis or 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. In the opinion of the investigator, a subject who is not likely to complete the study for what ever reason.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Duncan, MB BCh

Organizational Affiliation

Renovo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renovo CTU

City

Manchester

ZIP/Postal Code

M13 9XX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

19362676

Citation

Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.

Results Reference

derived

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Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects

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