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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Renovo

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Subjects who are pregnant or planning to get pregnant or lactating or not taking adequate contraceptive precautions. Subjects must use suitable mechanical forms of contraception (or abstinence) during the trial

• Subjects who are receiving the following drugs: cyclosporine, cyclophosphamide, taxol or warfarin

• Subjects who have pre-existing clinically significant neurological conditions

• In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason