Investigation Into the Safety of Intradermal Juvidex (M6P) Administered to Wounds of Healthy Subjects
Condition: Cicatrix; Re-epithelialisation
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Each subject received a total of four wounds, two 3mm punch biopsies (at least 5cm apart) to
      the upper, inner aspect of each arm.

      Subjects served as their own control, i.e. one punch biopsy on Arm 1 received Juvidex and the
      other punch biopsy received Placebo or Standard Care. Arm 2 punch biopsies received the same
      treatments as for Arm 1 but in reverse, i.e. treatments were matched across the arms.

      On Day 0 the two areas for punch biopsies on Arm 1 were marked and anaesthetised and
      randomised to receive Juvidex or Placebo. Prior to wounding sites were injected intradermally
      with 100μl investigational product per site. Juvidex was dosed at 50, 100, 200, 300, 400, and
      600mM.

      On Day 1 (24 h later) wounds were dosed as on Day 0 but with 200μl investigational product
      per site. On Day 3 the biopsy sites on Arm 1 were excised to determine re-epithelialisation.

      Arm 2 treatments and punch biopsies were carried out on Day 3, with further dosing 24 h later
      on Day 4 (as with Arm 1 wounding and treatments). These biopsy sites were excised on Day 8 of
      the study to obtain a 5 day-old wound.

      The randomisation of the treatment allowed for control of possible positional effects on
      healing. One subject in each group was randomised to receive only Placebo and Standard Care
      to their biopsy wounds.
    

Intervention name(s): Juvidex; Juvidex; Juvidex; Juvidex; Juvidex; Juvidex; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intradermal Juvidex, 100μl of 50mM (1.41mg/100μl) administered just prior to wounding and 200μl administered 24 h later; Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered just prior to wounding and 200μl administered 24 h later; Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered just prior to wounding and 200μl administered 24 h later; Intradermal Juvidex, 100μl of 300mM (8.46mg/100μl) administered just prior to wounding and 200μl administered 24 h later; Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered just prior to wounding and 200μl administered 24 h later; Intradermal Juvidex, 100μl of 600mM (16.93mg/100μl) administered just prior to wounding and 200μl administered 24 h later; Intradermal Placebo (0.9% phosphate buffered saline, pH 7.0), 100μl administered just prior to wounding and 200μl administered 24 later
Other intervention name(s): Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cicatrix; Scar; Wound-healing; Re-epithelialisation; RN1004; Mannose-6-phosphate; M6P; Juvidex