Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00847925
First received: February 17, 2009
Last updated: February 18, 2009
Last verified: February 2009

February 17, 2009
February 18, 2009
November 2001
September 2003   (final data collection date for primary outcome measure)
Scar severity [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00847925 on ClinicalTrials.gov Archive Site
Treatment local and systemic tolerance [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects
A Double Blind, Placebo and Standard Care Controlled, Randomised Study to Investigate the Clinical Safety and Toleration, Wound Healing and Antiscarring Potential of Two Applications of Intradermal RN1001 (Avotermin) in Healthy Male Subjects

A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects

Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject served as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing and subsequent scarring. Subjects were initially dosed and wounded (incisions and punch biopsies) on Day 0 and re-dosed on Day 1. On Day 3, Arm 1 incisions and punch biopsies were re-dosed as per Day 0 and excised, and re-dosed again on Day 4. Arm 2 punch biopsies were excised at Day 5 but not re-dosed. Healed incisions/scars on Arm 2 were excised for histological analysis after 12 months and not re-dosed. All subjects, regardless of treatment were treated according to best practices for moist wound healing.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Cicatrix
Drug: Avotermin (RN1001)
100ul/linear cm of wound. Dosed before surgery and 24h later
  • A
    50ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • B
    20ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • C
    5ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • D
    100ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • E
    500ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • F
    0.25ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • G
    1ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • H
    20ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
  • I
    50ng Avotermin/100ul
    Intervention: Drug: Avotermin (RN1001)
Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
September 2003
September 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy, non-Afro-Caribbean, male subjects aged 18-45 years inclusive.
  • Weight between 60 and 150kg and a body mass index between 15 - 55 kg/m2.
  • 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 Criteria:

  • Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring.
  • Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
  • Subjects with tattoos or previous scars in the areas to be biopsied.
  • Subjects, who on direct questioning and physical examination, have evidence of any past or present clinically significant disease and 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, certain prescribed or investigational drug in the three weeks prior to Day 0 and in particular topical or systemic steroids, and anti-coagulant drugs. Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements, inhaled salbutamol, thyroxine replacement therapy, OTC cold remedies.
  • Subjects who drink more than 28 units of alcohol per week (1 unit = ½ pint of beer (285mls) or 25ml of spirits or 1 glass of wine).
  • Subjects who have current 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 study for what ever reason.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00847925
RN1001-309-1002
No
Mark Cooper, Renovo
Renovo
Not Provided
Principal Investigator: Jonathan Duncan, MB BCh Renovo
Renovo
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP