NCT00978302

Brief Summary

The purpose of this study is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2001

Shorter than P25 for phase_1

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

May 1, 2001

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
8.1 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

3 months

First QC Date

September 15, 2009

Last Update Submit

September 15, 2009

Conditions

CicatrixWound Healing

Keywords

CicatrixScarWound healingAvoterminTGF beta 3JuvistaRN1001

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and local toleration of various dose levels of avotermin (Juvista) injected intradermally into healthy male volunteers.

    Days 0 and 1 and either 3 and 4 or 7 and 8 in addition to Day 10. A single post-trial follow-up was made between days 17-24.

Secondary Outcomes (2)

  • To determine the systemic PK of various dose levels of avotermin (Juvista) injected intradermally.

    Days 0 and 1 and either 3 and 4 or 7 and 8, in addition to day 10. A single post-trial follow-up was made between days 17-24.

  • To determine the histological effects (re-epithelialisation and wound healing) of avotermin (Juvista) injected intradermally.

    Days 3, 7 and 10.

Study Arms (2)

Placebo (vehicle)

PLACEBO COMPARATOR
Drug: Placebo (vehicle)

Avotermin

EXPERIMENTAL
Drug: Avotermin

Interventions

AvoterminDRUG

Intradermal injection, 50ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later

Also known as: RN1001, Juvista, TGFbeta 3
Avotermin
Placebo (vehicle)DRUG

Intradermal injection at time of biopsy and again 24 h later

Placebo (vehicle)

Eligibility Criteria

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

You may qualify if:

  • Healthy, caucasian male subjects
  • Weight between 60 and 150 kg and a BMI within the permitted range for their height using Quetelet's index (weight (kg)/height (m) squared. The permitted index is between 15-45 kg/m squared
  • 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 with evidence of hypertrophic or keloid scarring
  • Subjects with tattoos or previous scars in the biopsy areas
  • Subjects with evidence of any past or present clinically significant disease, particularly coagulation disorders, immuno-mediated conditions and skin diseases and allergies such as eczema
  • Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study
  • Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
  • Subjects who are taking or have taken any prescribed drug in the three weeks prior to day 0 and in particular topical or systemic steroids, anti-inflammatory and anti-coagulant drugs
  • Subjects who drink more than 28 units of alcohol per week
  • Subjects who have evidence of drug abuse
  • Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renovo Clinical Trials Unit

Manchester, Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, humanLtbp3 protein, zebrafish

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael J Davies

    Renovo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

May 1, 2001

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

GB(1)