CicatrixPhase 1NCT00984854
Investigation Into the Safety of Intradermal Juvidex (M6P) Administered to Wounds of Healthy Subjects
A Phase 1 study testing Juvidex in people with Cicatrix and Re-epithelialisation, run by Renovo at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Re-epithelialisation
- What is being tested?
- Juvidex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Jul 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Cicatrix, Re-epithelialisation
- Being tested
- Juvidex, Placebo
- Keywords
- Cicatrix, Scar, Wound-healing, Re-epithelialisation, RN1004, Mannose-6-phosphate, M6P, Juvidex
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 50mM (1.41mg/100μl) administered just prior to wounding and 200μl administered 24 h later
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered just prior to wounding and 200μl administered 24 h later
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered just prior to wounding and 200μl administered 24 h later
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 300mM (8.46mg/100μl) administered just prior to wounding and 200μl administered 24 h later
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered just prior to wounding and 200μl administered 24 h later
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 600mM (16.93mg/100μl) administered just prior to wounding and 200μl administered 24 h later
PlaceboDrug
Intradermal Placebo (0.9% phosphate buffered saline, pH 7.0), 100μl administered just prior to wounding and 200μl administered 24 later
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Juvidex | Experimental | Not described Receives: Drug: Juvidex |
| Placebo (vehicle) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and local toleration of various dose levels of Juvidex (RN1004) injected intradermally in healthy volunteers.
Measured: 22 Days
Secondary outcomes (3)
To determine the systemic PK of various dose levels of Juvidex injected intradermally.
Measured: 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.
Measured: Day 3 and 5
To find the maximum tolerated dose (MTD) of Juvidex
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startJan 2004
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeremy Bond, Principal investigator, RenovoJonathan Duncan, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984854
- Sponsor's protocol ID
- RN1004-319-1001
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00984854
- Acronym / sponsor ID
- RN1004-319-1001
- Conditions
- Cicatrix, Re-epithelialisation
- Keywords
- Cicatrix, Scar, Wound-healing, Re-epithelialisation, RN1004, Mannose-6-phosphate, M6P, Juvidex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal Juvidex | Experimental | Drug: Juvidex |
| Placebo (vehicle) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 50mM (1.41mg/100μl) administered just prior to wounding and 200μl administered 24 h later | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered just prior to wounding and 200μl administered 24 h later | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered just prior to wounding and 200μl administered 24 h later | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 300mM (8.46mg/100μl) administered just prior to wounding and 200μl administered 24 h later | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered just prior to wounding and 200μl administered 24 h later | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 600mM (16.93mg/100μl) administered just prior to wounding and 200μl administered 24 h later | Drug | Intradermal Juvidex |
| PlaceboIntradermal Placebo (0.9% phosphate buffered saline, pH 7.0), 100μl administered just prior to wounding and 200μl administered 24 later | Drug | Placebo (vehicle) |
Primary outcome
To assess the safety and local toleration of various dose levels of Juvidex (RN1004) injected intradermally in healthy volunteers.
Time frame: 22 Days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Bond principal investigator
Renovo
Jonathan Duncan principal investigator
Renovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Juvidex in people with Cicatrix and Re-epithelialisation, run by Renovo at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and local toleration of various dose levels of Juvidex (RN1004) injected intradermally in healthy volunteers. (time frame: 22 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009.