A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo

Study Overview
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Brief Summary
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RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model

Official Title
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A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects

Conditions
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Scar Improvement

Intervention / Treatment
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* Drug: Juvista (Avotermin)
* Drug: RN1006 (Avotermin)
* Drug: RN1006 (Avotermin)
* Drug: RN1006 (Avotermin)
* Drug: Juvista (Avotermin)
* Drug: Juvista (Avotermin)
* Drug: Juvista (Avotermin)
* Drug: RN1006 (Avotermin)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18-85 years who have given written informed consent Subjects with a body mass index within range 18-35 kg/m2 Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol Female subjects using a highly effective method (S) of contraception Exclusion Criteria: Subjects who have a history of keloid scarring, surgery within one year of the first dosing area Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised Subjects with any clinically significant medical condition or history of any condition which may impair wound healing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1a<br>250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. | Drug: Juvista (Avotermin)<br>* 250 ng, twice, intradermal injection, standard formulation<br>* Other names: RN1001;Drug: Placebo<br>* Placebo<br>|
| Experimental: 1b<br>250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. | Drug: RN1006 (Avotermin)<br>* 250 ng, intradermal injection, twice<br>* Other names: RN1006;Drug: Placebo<br>* Placebo<br>|
| Experimental: 1c<br>250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. | Drug: RN1006 (Avotermin)<br>* 205 ng, Intradermal injection, once<br>* Other names: RN1006;Drug: Placebo<br>* Placebo<br>|
| Experimental: 1d<br>500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. | Drug: RN1006 (Avotermin)<br>* 500ng, intradermal injection, once<br>* Other names: RN1006;Drug: Placebo<br>* Placebo<br>|
| Experimental: 2a<br>250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. | Drug: Juvista (Avotermin)<br>* 250 ng, intradermal injection, twice<br>* Other names: RN1001;Drug: Placebo<br>* Placebo<br>|
| Experimental: 2b<br>500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. | Drug: Juvista (Avotermin)<br>* 500 ng, intradermal injection, once<br>* Other names: RN1001;Drug: Placebo<br>* Placebo<br>|
| Experimental: 2c<br>500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. | Drug: Juvista (Avotermin)<br>* 500 ng, intradermal injection, once<br>* Other names: RN1001;Drug: Placebo<br>* Placebo<br>|
| Experimental: 2d<br>500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total). | Drug: RN1006 (Avotermin)<br>* 500 ng, intradermal injection, twice<br>* Other names: RN1006;Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global scar comparison scale |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence including specific assessment of local tolerability at the treated wound site |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, Comparison of two formulations, Improvement of scar appearance