CicatrixPhase 1NCT00978302
Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista)
A Phase 1 study testing Avotermin in people with Cicatrix and Wound Healing, run by Renovo at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Wound Healing
- What is being tested?
- Avotermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2001to Aug 2001
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, caucasian male subjects
- Weight between 60 and 150 kg and a BMI within the permitted range for their height using Quetelet's index (weight (kg)/height (m) squared. The permitted index is between 15-45 kg/m squared
- Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation
Who cannot join
- Subjects with evidence of hypertrophic or keloid scarring
- Subjects with tattoos or previous scars in the biopsy areas
- Subjects with evidence of any past or present clinically significant disease, particularly coagulation disorders, immuno-mediated conditions and skin diseases and allergies such as eczema
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study
- Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
- Subjects who are taking or have taken any prescribed drug in the three weeks prior to day 0 and in particular topical or systemic steroids, anti-inflammatory and anti-coagulant drugs
Show all 9Show fewer
- Subjects who drink more than 28 units of alcohol per week
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Renovo Clinical Trials Unit
Manchester, Manchester, M13 9XX
About this study
Official title: A Double Blind, Placebo (Vehicle) and Standard Care Controlled, Randomised, Parallel Group Study to Investigate the Clinical Safety, Toleration, Systemic Pharmacokinetics and Local Pharmacodynamics of Repeated, Escalating Concentrations of Intradermal RN1001 in Healthy Male Subjects.
The purpose of this study is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volunteers.
Read the detailed description
The study was split into two Cohorts: A and B. Volunteers in Cohort A were assigned to one of four dose groups receiving 50, 100, 500 and 1000ng/100μl/3mm punch biopsy. Volunteers were assigned sequentially in order of ascending dose. Within each dose group volunteers were further randomised to subgroup a, b or c. Each subject was set to receive four 3mm punch biopsies, two on each arm, and intradermal injection of avotermin, placebo or nothing (standard care).
On day 0 two 3mm punch biopsies were administered under local anaesthesia to the inner aspect of one arm of each subject following intradermal injection of avotermin, placebo or nothing. The four subjects in subgroup a received avotermin to one punch biopsy and placebo to the other. The four subjects in subgroup b received avotermin to one punch biopsy and standard care only to the other. The one subject in subgroup c was administered with intradermal placebo to one biopsy and standard care only to the other. 24 h later a further application of intradermal avotermin, placebo or nothing was applied.
While arm 1 was used as a study arm, arm 2 was used for safety procedures. Subjects were then randomised to return on Day 3 or 7 for excision of the first two punch biopsies. At the same time two punch biopsies and the same treatment regime was carried out on the second arm. These were dosed again 24 h later and all were excised on Day 10.
After determining safety and toleration of all doses in Cohort A, new subjects were assigned to Cohort B. These were allocated in ascending order to groups that would receive 1, 10, 50 and 100μg/100μl/3mm punch biopsy, following the same procedures that were used for Cohort A. Only after the first three groups reached Day 10 and the safety data was analysed would the final volunteers be recruited to the 100μg group.
- Conditions
- Cicatrix, Wound Healing
- Being tested
- Avotermin, Placebo (vehicle)
- Keywords
- Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvoterminDrug
Also called RN1001, Juvista, TGFbeta 3
Intradermal injection, 50ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
AvoterminDrug
Also called RN1001, Juvista, TGFbeta 3
Intradermal injection, 100ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
AvoterminDrug
Also called RN1001, Juvista, TGFbeta 3
Intradermal injection, 500ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
AvoterminDrug
Also called RN1001, Juvista, TGFbeta 3
Intradermal injection, 1000ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
AvoterminDrug
Also called RN1001, Juvista, TGFbeta 3
Intradermal injection, 1μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
AvoterminDrug
Also called RN1001, Juvista, TGFbeta 3
Intradermal injection, 10μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later
Placebo (vehicle)Drug
Intradermal injection at time of biopsy and again 24 h later
| Study group | Role | What they receive |
|---|---|---|
| Placebo (vehicle) | Placebo comparator | Not described Receives: Drug: Placebo (vehicle) |
| Avotermin | Experimental | Not described Receives: Drug: Avotermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and local toleration of various dose levels of avotermin (Juvista) injected intradermally into healthy male volunteers.
Measured: Days 0 and 1 and either 3 and 4 or 7 and 8 in addition to Day 10. A single post-trial follow-up was made between days 17-24.
Secondary outcomes (2)
To determine the systemic PK of various dose levels of avotermin (Juvista) injected intradermally.
Measured: Days 0 and 1 and either 3 and 4 or 7 and 8, in addition to day 10. A single post-trial follow-up was made between days 17-24.
To determine the histological effects (re-epithelialisation and wound healing) of avotermin (Juvista) injected intradermally.
Measured: Days 3, 7 and 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startMay 2001
- Primary completionAug 2001
- Study completionAug 2001
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael J Davies, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978302
- Sponsor's protocol ID
- RN1001-319-1001
- Status last verified
- Sep 2009
- First submitted
- 15 Sep 2009
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo (Vehicle) and Standard Care Controlled, Randomised, Parallel Group Study to Investigate the Clinical Safety, Toleration, Systemic Pharmacokinetics and Local Pharmacodynamics of Repeated, Escalating Concentrations of Intradermal RN1001 in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT00978302
- Acronym / sponsor ID
- RN1001-319-1001
- Conditions
- Cicatrix, Wound Healing
- Keywords
- Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Aug 2001 (actual)
- Study completion
- Aug 2001 (actual)
- First posted
- 16 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 is to determine the safety and local toleration and histological effects of various dose levels of avotermin (Juvista) injected intradermally in healthy male volunteers.
Detailed description
The study was split into two Cohorts: A and B. Volunteers in Cohort A were assigned to one of four dose groups receiving 50, 100, 500 and 1000ng/100μl/3mm punch biopsy. Volunteers were assigned sequentially in order of ascending dose. Within each dose group volunteers were further randomised to subgroup a, b or c. Each subject was set to receive four 3mm punch biopsies, two on each arm, and intradermal injection of avotermin, placebo or nothing (standard care).
On day 0 two 3mm punch biopsies were administered under local anaesthesia to the inner aspect of one arm of each subject following intradermal injection of avotermin, placebo or nothing. The four subjects in subgroup a received avotermin to one punch biopsy and placebo to the other. The four subjects in subgroup b received avotermin to one punch biopsy and standard care only to the other. The one subject in subgroup c was administered with intradermal placebo to one biopsy and standard care only to the other. 24 h later a further application of intradermal avotermin, placebo or nothing was applied.
While arm 1 was used as a study arm, arm 2 was used for safety procedures. Subjects were then randomised to return on Day 3 or 7 for excision of the first two punch biopsies. At the same time two punch biopsies and the same treatment regime was carried out on the second arm. These were dosed again 24 h later and all were excised on Day 10.
After determining safety and toleration of all doses in Cohort A, new subjects were assigned to Cohort B. These were allocated in ascending order to groups that would receive 1, 10, 50 and 100μg/100μl/3mm punch biopsy, following the same procedures that were used for Cohort A. Only after the first three groups reached Day 10 and the safety data was analysed would the final volunteers be recruited to the 100μg group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (vehicle) | Placebo comparator | Drug: Placebo (vehicle) |
| Avotermin | Experimental | Drug: Avotermin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, caucasian male subjects
- Weight between 60 and 150 kg and a BMI within the permitted range for their height using Quetelet's index (weight (kg)/height (m) squared. The permitted index is between 15-45 kg/m squared
- Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation
Key exclusion criteria (9 listed)
- Subjects with evidence of hypertrophic or keloid scarring
- Subjects with tattoos or previous scars in the biopsy areas
- Subjects with evidence of any past or present clinically significant disease, particularly coagulation disorders, immuno-mediated conditions and skin diseases and allergies such as eczema
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study
- Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
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 |
|---|---|---|
| AvoterminAlso: RN1001, Juvista, TGFbeta 3Intradermal injection, 50ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later | Drug | Avotermin |
| AvoterminAlso: RN1001, Juvista, TGFbeta 3Intradermal injection, 100ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later | Drug | Avotermin |
| AvoterminAlso: RN1001, Juvista, TGFbeta 3Intradermal injection, 500ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later | Drug | Avotermin |
| AvoterminAlso: RN1001, Juvista, TGFbeta 3Intradermal injection, 1000ng/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later | Drug | Avotermin |
| AvoterminAlso: RN1001, Juvista, TGFbeta 3Intradermal injection, 1μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later | Drug | Avotermin |
| AvoterminAlso: RN1001, Juvista, TGFbeta 3Intradermal injection, 10μg/100μl/3mm punch biopsy, once at time of biopsy and again 24 h later | Drug | Avotermin |
| Placebo (vehicle)Intradermal injection at time of biopsy and again 24 h later | Drug | Placebo (vehicle) |
Primary outcome
To determine the safety and local toleration of various dose levels of avotermin (Juvista) injected intradermally into healthy male volunteers.
Time frame: Days 0 and 1 and either 3 and 4 or 7 and 8 in addition to Day 10. A single post-trial follow-up was made between days 17-24.
2 secondary outcomes
To determine the systemic PK of various dose levels of avotermin (Juvista) injected intradermally.
Time frame: Days 0 and 1 and either 3 and 4 or 7 and 8, in addition to day 10. A single post-trial follow-up was made between days 17-24.
To determine the histological effects (re-epithelialisation and wound healing) of avotermin (Juvista) injected intradermally.
Time frame: Days 3, 7 and 10.
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 16 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.
Michael J Davies 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 Avotermin in people with Cicatrix and Wound Healing, 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 3 inclusion and 9 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 16 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 determine the safety and local toleration of various dose levels of avotermin (Juvista) injected intradermally into healthy male volunteers. (time frame: Days 0 and 1 and either 3 and 4 or 7 and 8 in addition to Day 10. A single post-trial follow-up was made between days 17-24.). 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 16 Sep 2009.