E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 1.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036892 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess early wound healing in male and post-menopausal female subjects following administration of intradermal RN1002. |
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E.2.2 | Secondary objectives of the trial |
To assess safety and tolerability of intradermal RN1002 in male and post-menopausal female subjects. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male subjects aged 18-85 years, and female subjects who are at least two years post-menopausal (24 calendar months after last natural menses) who have given written informed consent.
Subjects with, in the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol |
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E.4 | Principal exclusion criteria |
1. Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring.
2. Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial.
3. Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
4.Subjects who have had surgery in the area to be biopsied within one year of the first dosing day.
5. Subjects with a history of a bleeding disorder.
6. Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial
7.Subjects with any clinically significant medical condition or history that would impair wound healing
8. Subjects with a history of hypersensitivity to any of the drugs or dressings used in this trial.
9. Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
10. Subjects who are taking regular, continuous, oral corticosteroid therapy.
11. Subjects undergoing investigations or changes in management for an existing medical condition.
12. Subjects with a history of drug abuse.
13. Subjects with a positive drugs of abuse test for cocaine, amphetamines, methamphetamines, opiates or benzodiazepines during the screening period.
14. Subjects who, in the opinion of the investigator, are unlikely to complete the trial for whatever reason.
15. Female subjects who are currently taking any form of hormone replacement therapy or contraceptive medication.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary trial endpoint will be the distance travelled by the epithelium over the biopsy site at Study Day 3.. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient, last visit as defined in the protocol |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |