Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

Exclusion Criteria

• •have clinically significant laboratory abnormalities at screening
• •have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, coagulopathic disorder or other condition that would preclude participation in the study
• •have received treatment for a severe, uncontrolled inflammatory disease or allergic condition within three months of screening
• •have a life expectancy ≤ 2 years
• •have a history of alcoholism or drug addiction or abuse within 5 years
• •have evidence of a clinically significant abnormality upon evaluation of 12 lead ECG
• •have evidence of any past or present clinically significant medical condition, including skin disease, that would impair wound healing
• •have a history of keloid scar formation
• •have existing scarring in the abdominal area of study that would interfere with the efficacy assessments
• •have a history of (within the past 5 years) or an active malignancy, other than breast cancer
• •have a breast cancer that has been staged at Stage IIIB, IIIC or IV
• •have received a cytotoxic agent or have been treated with radiation within 90 days of screening and/or, in the opinion of the investigator, will likely require treatment in the 30 day period following the administration of study medication
• •have received anticoagulation medication within 5 days of dosing with study medication
• •have participated in any study involving an investigational product within 30 days before dosing with study medication
• •have routinely used tobacco products within 6 months preceding the study period