Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects

NCT00977951 | Completed Phase 1

• 1 other identifier: RN1001-319-1004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Cicatrix; Wound Healing

Keywords

Cicatrix; Scar; Avotermin; Juvista; RN1001; TGF beta 3

Outcome Measures

Primary Outcomes (2)

• To investigate genomic expression profiles after exposure to either intradermal avotermin (Juvista) or placebo

  Days 3 and 5

• To investigate the genomic expression profiles of reduced scarring in healthy male volunteers

  Days 3 and 5 and month 6

Secondary Outcomes (4)

• To collect further safety and toleration data for intradermal RN1001

  Day 15 and month 6

• To assess systemic exposure following intradermal RN1001 before and after minor skin incisions

  Day 15 and month 6

• To confirm accelerated healing associated with intradermal RN1001

  Days 3 and 5

• To investigate how to power a genomic analysis study optimally for the detection of gene expression profiles associated with accelerated healing, drug delivery and improved scarring.

  Days 3 and 5

Study Arms (2)

Intradermal avotermin

EXPERIMENTAL

Drug: Intradermal avotermin

Placebo (vehicle)

PLACEBO COMPARATOR

Drug: Placebo (vehicle); Drug: Placebo

Interventions

Intradermal avotermin DRUG

50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4

Also known as: Juvista, RN1001, TGF beta 3

Intradermal avotermin

Placebo (vehicle) DRUG

Placebo administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4

Placebo (vehicle)

Placebo DRUG

50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6

Placebo (vehicle)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo Ltd

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, human; Transforming Growth Factor beta3

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transforming Growth Factor beta; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; TGF-beta Superfamily Proteins; Proteins; Biological 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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: September 1, 2002
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

GB (1)