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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a prospective, single center, randomized, double-blinded, placebo-controlled, exploratory phase I clinical trial in healthy male subjects to investigate the safety and tolerability of the cytokine based gel APOSEC™. The proof of safety and tolerability of APOSEC™ is the primary objective. The secondary objective is to measure the extent of wound healing of APOSEC™.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna

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