Investigation Into the Safety of Intradermal Juvidex (M6P) Administered to Wounds of Healthy Subjects

NCT00984854 | Completed Phase 1

• 1 other identifier: RN1004-319-1001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the safety and toleration of various doses of intradermal Juvidex (mannose-6-phosphate) administered to punch biopsies of normal subjects.

Conditions

Cicatrix; Re-epithelialisation

Keywords

Cicatrix; Scar; Wound-healing; Re-epithelialisation; RN1004; Mannose-6-phosphate; M6P; Juvidex

Outcome Measures

Primary Outcomes (1)

• To assess the safety and local toleration of various dose levels of Juvidex (RN1004) injected intradermally in healthy volunteers.

  22 Days

Secondary Outcomes (3)

• To determine the systemic PK of various dose levels of Juvidex injected intradermally.

  22 days

• To determine the histological effects on wound healing (re-epithelialisation, inflammatory cell infiltrate, angiogenesis and matrix deposition) of intradermal injections of Juvidex in healthy subjects.

  Day 3 and 5

• To find the maximum tolerated dose (MTD) of Juvidex

  22 days

Study Arms (2)

Intradermal Juvidex

EXPERIMENTAL

Drug: Juvidex

Placebo (vehicle)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Juvidex DRUG

Intradermal Juvidex, 100μl of 50mM (1.41mg/100μl) administered just prior to wounding and 200μl administered 24 h later

Also known as: Mannose-6-phosphate, M6P, RN1004

Intradermal Juvidex

Placebo DRUG

Intradermal Placebo (0.9% phosphate buffered saline, pH 7.0), 100μl administered just prior to wounding and 200μl administered 24 later

Placebo (vehicle)

Eligibility Criteria

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

You may qualify if:

• Clinically healthy male and female subjects aged 18-45 years inclusive
• Weight between 40 and 150kg and a BMI within the permitted range for their height using Quetelet's index - weight (kg)/height²(m). The permitted index is between 15 - 55 kg/m2

You may not qualify if:

• Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied
• Subjects who have had surgery in the area to be biopsied within the previous 12 months
• Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
• Subjects, who on direct questioning and physical examination, have evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, 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; or to any excipients or vehicle in the formulation or delivery vehicle
• 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 drugs in the four weeks prior to Day 0 and in particular topical or systemic steroids, anti-inflammatory, anti-coagulant, antiproliferative drugs and antibiotics Certain drugs are not excluded in this trial, including OTC analgesics such as paracetamol and codeine, vitamin and mineral supplements and OTC cold remedies and hormonal contraceptives. If antibiotics are required after Day 0, this will not exclude subjects from continuation in this trial and the data will be recorded in the CRF
• Subjects who have taken part in a clinical trial within 3 months prior to admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not
• Subjects who have any clinical evidence of severe ongoing or prolonged depression or mental illness
• Subjects who smoke more than 20 cigarettes a day
• 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, (unless deemed NOT to be a hepatitis B carrier by the local Public Health laboratory)
• Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

mannose-6-phosphate

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeremy Bond

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: January 1, 2004
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

GB (1)