Status:
COMPLETED
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
Lead Sponsor:
Medical University of Vienna
Conditions:
Healthy
Artificial Dermal Wound
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief 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 cyto...
Detailed Description
APOSEC™ is a human product derived from lyophilized conditional medium of peripheral blood mononuclear cells (PBMC) following 24 hours cultivation after irradiation with 60Gy. The soluble factors prod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02284360
Start Date
October 1 2014
End Date
June 1 2015
Last Update
September 28 2015
Active Locations (1)
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1
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Vienna, Austria, 1090