Status:
COMPLETED
Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Wound Healing
Eligibility:
MALE
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to further determine the safety and toleration of intradermal avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles
Detailed Description
Subjects were allocated to two groups. Group 1 had scheduled visits on Day 0, 1, 3 and 4 while group 2 were scheduled for Day 0, 1, 5 and 6. Follow-up post-trial safety assessments were made on Day 10...
Eligibility Criteria
Inclusion
- Healthy, Caucasian, male subjects aged 18-45 years inclusive.
- Weight between 60-100 kg and a BMI within the permitted range for their height using Quetelet's index - weight (kg)/height²(m). The permitted index is between 18-28.
- Non-smokers, or ex-smokers that have not smoked for at least 3 months prior to screening.
Exclusion
- Subjects who have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.
- Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
- Subjects who have evidence of any past or present clinically significant disease, particularly coagulation disorders, immuno-mediated conditions and skin diseases and allergies, such as clinically significant eczema.
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.
- Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination.
- Subjects who are taking, or have taken, certain prescribed or investigational drugs in the three weeks prior to Day 0 and in particular topical or systemic steroids, anti-inflammatory and anti-coagulant drugs. Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements and OTC cold remedies.
- Subjects who drink more than 28 units of alcohol per week (1 unit = 1/2 pint of beer (285mls) or 25ml of spirits or 1 glass of wine).
- 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 or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.
- Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.
- Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high risk group.
- In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00977951
Start Date
September 1 2002
End Date
September 1 2003
Last Update
September 16 2009
Active Locations (1)
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1
Renovo Ltd
Manchester, United Kingdom, M13 9XX