NCT00978367

Brief Summary

The purpose of this study is to investigate the dosing frequency, wound healing (re-epithelialisation) and anti-scarring effects of one, three and five applications of two concentrations of intradermal RN1001 in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2002

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

February 1, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

9 months

First QC Date

September 15, 2009

Last Update Submit

September 15, 2009

Conditions

CicatrixWound HealingRe-epithelialization

Keywords

CicatrixScarAvoterminJuvistaRN1001TGF beta 3

Outcome Measures

Primary Outcomes (1)

  • To determine the dosing frequency of various concentrations of intradermal avotermin (Juvista) for the improvement of early wound healing and re-epithelialisation, as determined by measuring total wound diameter

    Day 5 post surgery

Secondary Outcomes (4)

  • To determine the safety and toleration of various concentrations of avotermin (Juvista) applied by intradermal injection at various timepoints

    Days 0-14 post-wounding

  • To determine the systemic exposure of various concentrations of avotermin (Juvista) applied by intradermal injection at various timepoints

    Days 0-14 post-wounding

  • To determine the gross and histological endpoints (re-epithelialisation and wound healing) of various concentrations of avotermin (Juvista) applied by intradermal injection at various dosing frequencies

    0-6 months post-wounding

  • To determine the anti-scarring potential of two doses of avotermin (Juvista) when applied by intradermal injection at various dosing frequencies

    Day 5 and 6 months post-wounding

Study Arms (2)

Drug, intradermal avotermin (Juvista)

EXPERIMENTAL
Drug: Avotermin

Placebo (vehicle)

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AvoterminDRUG

5 ng or 50 ng/100 ul avotermin applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on day 5 just prior to excision of the wound with a 5 mm surgical ellipse

Also known as: Juvista, RN1001, TGF beta 3
Drug, intradermal avotermin (Juvista)
PlaceboDRUG

Placebo applied by intradermal injection to one of two 3 mm punch biopsies on each arm just prior to surgery (on day 0) and again on day 5 just prior to excision of the wound with a 5 mm surgical ellipse

Placebo (vehicle)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, non-Caribbean, male subjects aged 18-45 years inclusive
  • Weight between 60-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-45 kg/m(squared)) (weight (kg)/height (squared)(m))
  • Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation

You may not qualify if:

  • Subjects who have a history or evidence of hypertrophic or keloid scarring
  • Subjects with tattoos or previous scars in the area to be biopsied
  • Subjects who have evidence of any past or present clinically significant disease, particularly coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renovo Ltd

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, humanTransforming Growth Factor beta3

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transforming Growth Factor betaCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTGF-beta Superfamily ProteinsProteinsBiological Factors

Study Officials

  • Michael J Davies

    Renovo

    PRINCIPAL INVESTIGATOR

  • Jonathan Duncan

    Renovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

February 1, 2002

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

GB(1)