Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects

NCT00984581 | Completed Phase 1

• 1 other identifier: RN1001-319-1006
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.

Conditions

Cicatrix; Wound Healing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.

  Month 6

Secondary Outcomes (2)

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

  Month 6

• To assess the anti-scarring potential of intradermal Juvista in a young female population.

  Month 6-12

Study Arms (2)

Intradermal avotermin

EXPERIMENTAL

Drug: Avotermin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Avotermin DRUG

Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6

Also known as: TGFbeta 3, Juvista

Intradermal avotermin

Placebo DRUG

Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1

Placebo

Eligibility Criteria

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

You may qualify if:

• Clinically healthy, female subjects aged 18-45 years
• Weight between 40-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-35 kg/m(squared)). Weight(kg)/height (squared)(m)
• Subjects who use appropriate non-pharmaceutical methods of contraception or are not likely to become pregnant for the duration of the trial

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
• Subjects with a personal history of a bleeding disorder
• Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
• Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial
• Subjects with any clinically significant medical condition that would impair wound healing including significant rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled digestive heart failure, active malignancy, immunosuppressive, radiation or chemotherapy within the last three months, a history of radiotherapy to the arm or diabetes mellitus
• Subjects with a history of clinically significant 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, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, HRT, oral contraceptive pill, other pharmaceutical methods of contraception or anticoagulant drugs in the thirty days prior to Day 0
• 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 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 and subjects who at any point have a positive pregnancy test
• Subjects who are pregnant or become pregnant during the trial
• 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

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, human; Ltbp3 protein, zebrafish

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Duncan

  Renovo

  PRINCIPAL INVESTIGATOR

• Jeremy Bond

  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 25, 2009
• Study Start: April 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

GB (1)