A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo (RN1006)

Renovo

Status and phase: Completed; Phase 1

Conditions: Scar Improvement

Treatments: Drug: Placebo; Drug: RN1006 (Avotermin); Drug: Juvista (Avotermin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01029158

RN1006-0100

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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84 participants in 8 patient groups

1a

Experimental group

Description:

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.

Treatment:

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

Drug: Placebo

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

1b

Experimental group

Description:

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.

Treatment:

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)

Drug: Placebo

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)

1c

Experimental group

Description:

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

Treatment:

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)

Drug: Placebo

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)

1d

Experimental group

Description:

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

Treatment:

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)

Drug: Placebo

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)

2a

Experimental group

Description:

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.

Treatment:

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

Drug: Placebo

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

2b

Experimental group

Description:

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

Treatment:

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

Drug: Placebo

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

2c

Experimental group

Description:

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.

Treatment:

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

Drug: Placebo

Drug: Juvista (Avotermin)

Drug: Juvista (Avotermin)

2d

Experimental group

Description:

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).

Treatment:

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)

Drug: Placebo

Drug: RN1006 (Avotermin)

Drug: RN1006 (Avotermin)