RJV001 Study in Adults Receiving Abdominoplasty

Exclusion Criteria

• •1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
• •2. Subject has a significant active systemic or localized abdominal infection.
• •3. Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
• •4. Subject is taking any medications that affect clotting and/or platelet function. This includes, but is not limited to, nonsteroidal anti-inflammatory medications (including low dose aspirin for prophylaxis), heparin (including low molecular weight heparin), Coumadin, and factor Xa agents such as Clopidogrel bisulfate (Plavix) and apixaban (Eliquis), etc. The use of such medications is precluded within 7 days prior to Visit 2/Baseline.
• •5. Subject is immunocompromised, in the opinion of the investigator, based on their medical condition (e.g., positive for human immunodeficiency virus, malignancy), medication use, or other factors.
• •6. Subject has any clinically significant medical abnormality or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. This includes conditions (e.g., gastrointestinal surgery) that may interfere with metabolism or excretion.
• •7. Subject is currently enrolled in an investigational drug or device study.
• •8. Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 2/Baseline.
• •9. Subject has a history of sensitivity to RJV001, other collagenases, or any of the other ingredients in the test articles.
• •10. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.