NCT01029158

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

1.1 years

First QC Date

December 4, 2009

Last Update Submit

December 7, 2010

Conditions

Scar Improvement

Keywords

Healthy volunteersComparison of two formulationsImprovement of scar appearance

Outcome Measures

Primary Outcomes (1)

  • Global scar comparison scale

    12 months

Secondary Outcomes (1)

  • Adverse event incidence including specific assessment of local tolerability at the treated wound site

    12 months

Study Arms (8)

1a

EXPERIMENTAL

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)Drug: Placebo

1b

EXPERIMENTAL

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)Drug: Placebo

1c

EXPERIMENTAL

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

Drug: RN1006 (Avotermin)Drug: Placebo

1d

EXPERIMENTAL

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

Drug: RN1006 (Avotermin)Drug: Placebo

2a

EXPERIMENTAL

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)Drug: Placebo

2b

EXPERIMENTAL

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

Drug: Juvista (Avotermin)Drug: Placebo

2c

EXPERIMENTAL

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)Drug: Placebo

2d

EXPERIMENTAL

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)Drug: Placebo

Interventions

Juvista (Avotermin)DRUG

250 ng, twice, intradermal injection, standard formulation

Also known as: juvista, RN1001
1a
RN1006 (Avotermin)DRUG

250 ng, intradermal injection, twice

Also known as: RN1006
1b
PlaceboDRUG

Placebo

1a1b1c1d2a2b2c2d

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renovo CTU

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Interventions

TGFB3 protein, human

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 9, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

December 9, 2010

Record last verified: 2010-12

Locations

GB(1)