A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds

• Register: ClinicalTrials.gov
• Last refreshed on: 6 October 2015
• Main ID: NCT02284360
• Date of registration: 30/10/2014
• Prospective Registration: No
• Primary sponsor: Medical University of Vienna
• Public title: A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds
• Scientific title: A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds
• Date of first enrolment: October 2014
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02284360
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male subjects with 18-50 years of age at the day of inclusion

- Written informed consent will be obtained prior to screening examination

- BMI of 19-27 (extremes included)

- Subjects are in good clinical and mental health as established by medical history,
physical examination, vital signs, electrocardiogram, results of biochemistry,
hematology, virology and urine analysis at the Screening Visit

Exclusion Criteria:

- Lack of willingness or capacity to co-operate appropriately

- Regular use of medications

- History of malignancies

- History of wound healing abnormalities

- Chronic dermatological disease

- History of chronic autoimmune diseases such as rheumatoid arthritis, inflammatory
bowel disease, diabetes mellitus, Lupus erythematodus

- Tattoos in the region of planned punch biopsy

- Positive HIV serology or evidence of active hepatitis

- Allergy requiring medical treatment within 4 weeks before study initiation

- Active infection of fever > 38°C within 7 days prior randomisation

- Blood donation within 4 weeks before study initiation

- Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or
physical examination

- Participation in another clinical trial with an investigational day within 4 weeks
before study participation



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Artificial Dermal Wound

Intervention(s)

Drug: APOSEC™ for cutaneous use

Primary Outcome(s)

- The number of subjects experiencing Adverse Events, Serious Adverse Events, Dose-limiting toxicities or local tolerability issues as a measure of Safety and Tolerability will be assessed throughout the study period. [Time Frame: day 0 to day 17]

Secondary Outcome(s)

- Changes in wound size between baseline and End of Treatment (EOT) assessed by photographic analysis. [Time Frame: day 1 to day 7]

Investigator satisfaction assessment on applicability of the gel [Time Frame: day 0 - day 6]

Presence or absence of complete wound closure at End of Treatment (EOT) after Verum vs. Placebo administration. [Time Frame: day 7]

Presence or absence of re-epithelization and angiogenesis assessed by the markers CD31 and vWF. [Time Frame: day 1 / day 7]

- Scarring formation with respect to induration of palpable scar tissue. [Time Frame: day 7]

Secondary ID(s)

MarsyasI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors