Wound Healing MedDRA version: 1.1 Level: PT Classification code 10036892
Conditions
Interventions
Product Name: RN1002
Product Code: RN1002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Estradiol
CAS Number: 50-28-2
Sponsors
Renovo Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess early wound healing in male and post-menopausal female subjects following administration of intradermal RN1002.;Secondary Objective: To assess safety and tolerability of intradermal RN1002 in male and post-menopausal female subjects.;Primary end point(s): The primary trial endpoint will be the distance travelled by the epithelium over the biopsy site at Study Day 3.. | — |
Countries
United Kingdom
Outcome results
None listed