Investigation Into the Safety of Intradermal Juvidex (M6P) Administered to Wounds of Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT00984854|
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : September 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cicatrix Re-epithelialisation||Drug: Juvidex Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Trial to Investigate the Clinical Safety, Local Toleration, and Systemic Pharmacokinetics of Repeated, Escalating Concentrations of Intradermal RN1004 to Wounds of Healthy Subjects.|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||July 2004|
|Actual Study Completion Date :||July 2004|
|Experimental: Intradermal Juvidex||
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
|Placebo Comparator: Placebo (vehicle)||
Intradermal Placebo (0.9% phosphate buffered saline, pH 7.0), 100μl administered just prior to wounding and 200μl administered 24 later
- To assess the safety and local toleration of various dose levels of Juvidex (RN1004) injected intradermally in healthy volunteers. [ Time Frame: 22 Days ]
- To determine the systemic PK of various dose levels of Juvidex injected intradermally. [ Time Frame: 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. [ Time Frame: Day 3 and 5 ]
- To find the maximum tolerated dose (MTD) of Juvidex [ Time Frame: 22 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984854
|Manchester, United Kingdom, M13 9XX|
|Principal Investigator:||Jeremy Bond||Renovo|
|Principal Investigator:||Jonathan Duncan||Renovo|