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

NCT ID: NCT01029158

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-11-30

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

Detailed Description

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Conditions

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Scar Improvement

Keywords

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Healthy volunteers Comparison of two formulations Improvement of scar appearance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1a

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.

Group Type EXPERIMENTAL

Juvista (Avotermin)

Intervention Type DRUG

250 ng, twice, intradermal injection, standard formulation

Placebo

Intervention Type DRUG

Placebo

1b

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.

Group Type EXPERIMENTAL

RN1006 (Avotermin)

Intervention Type DRUG

250 ng, intradermal injection, twice

Placebo

Intervention Type DRUG

Placebo

1c

250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.

Group Type EXPERIMENTAL

RN1006 (Avotermin)

Intervention Type DRUG

205 ng, Intradermal injection, once

Placebo

Intervention Type DRUG

Placebo

1d

500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.

Group Type EXPERIMENTAL

RN1006 (Avotermin)

Intervention Type DRUG

500ng, intradermal injection, once

Placebo

Intervention Type DRUG

Placebo

2a

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.

Group Type EXPERIMENTAL

Juvista (Avotermin)

Intervention Type DRUG

250 ng, intradermal injection, twice

Placebo

Intervention Type DRUG

Placebo

2b

500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.

Group Type EXPERIMENTAL

Juvista (Avotermin)

Intervention Type DRUG

500 ng, intradermal injection, once

Placebo

Intervention Type DRUG

Placebo

2c

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.

Group Type EXPERIMENTAL

Juvista (Avotermin)

Intervention Type DRUG

500 ng, intradermal injection, once

Placebo

Intervention Type DRUG

Placebo

2d

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).

Group Type EXPERIMENTAL

RN1006 (Avotermin)

Intervention Type DRUG

500 ng, intradermal injection, twice

Placebo

Intervention Type DRUG

Placebo

Interventions

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Juvista (Avotermin)

250 ng, twice, intradermal injection, standard formulation

Intervention Type DRUG

RN1006 (Avotermin)

250 ng, intradermal injection, twice

Intervention Type DRUG

RN1006 (Avotermin)

205 ng, Intradermal injection, once

Intervention Type DRUG

RN1006 (Avotermin)

500ng, intradermal injection, once

Intervention Type DRUG

Juvista (Avotermin)

250 ng, intradermal injection, twice

Intervention Type DRUG

Juvista (Avotermin)

500 ng, intradermal injection, once

Intervention Type DRUG

Juvista (Avotermin)

500 ng, intradermal injection, once

Intervention Type DRUG

RN1006 (Avotermin)

500 ng, intradermal injection, twice

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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juvista RN1001 RN1006 RN1006 RN1006 Juvista RN1001 Juvista RN1001 Juvista RN1001 RN1006

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Renovo

INDUSTRY

Sponsor Role lead

Responsible Party

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Renovo

Locations

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Renovo CTU

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RN1006-0100

Identifier Type: -

Identifier Source: org_study_id