Status:
COMPLETED
Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista)
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Wound Healing
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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.
Detailed Description
The study was split into two Cohorts: A and B. Volunteers in Cohort A were assigned to one of four dose groups receiving 50, 100, 500 and 1000ng/100μl/3mm punch biopsy. Volunteers were assigned sequen...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2001
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00978302
Start Date
May 1 2001
End Date
August 1 2001
Last Update
September 16 2009
Active Locations (1)
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1
Renovo Clinical Trials Unit
Manchester, Manchester, United Kingdom, M13 9XX