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

NCT00847925 | Completed Phase 1

• 1 other identifier: RN1001-309-1002
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cicatrix

Outcome Measures

Primary Outcomes (1)

• Scar severity

  12 Months

Secondary Outcomes (1)

• Treatment local and systemic tolerance

  12 Months

Study Arms (9)

A

OTHER

50ng Avotermin/100ul

Drug: Avotermin (RN1001)

B

OTHER

20ng Avotermin/100ul

Drug: Avotermin (RN1001)

C

OTHER

5ng Avotermin/100ul

Drug: Avotermin (RN1001)

D

OTHER

100ng Avotermin/100ul

Drug: Avotermin (RN1001)

E

OTHER

500ng Avotermin/100ul

Drug: Avotermin (RN1001)

F

OTHER

0.25ng Avotermin/100ul

Drug: Avotermin (RN1001)

G

OTHER

1ng Avotermin/100ul

Drug: Avotermin (RN1001)

H

OTHER

20ng Avotermin/100ul

Drug: Avotermin (RN1001)

I

OTHER

50ng Avotermin/100ul

Drug: Avotermin (RN1001)

Interventions

Avotermin (RN1001) DRUG

100ul/linear cm of wound. Dosed before surgery and 24h later

A; B; C; D; E; F; G; H; I

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo CTU

Manchester, M13 9XX, United Kingdom

Location

Related Publications (1)

• 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. doi: 10.1016/S0140-6736(09)60322-6.

  PMID: 19362676 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, human

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Duncan, MB BCh

  Renovo

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: November 1, 2001
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: February 19, 2009

Record last verified: 2009-02

Locations

GB (1)