Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
Condition: Scar Formation
Intervention: GBT009; Placebo
Intervention description: Intradermal Injection following surgery; Intradermal Injection following surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GBT009; incisional scar; breast reconstruction

Summary:

      The primary objective of this study is to assess whether intradermal injections of GBT009
      along full thickness incisions following surgery results in an improvement in scar
      appearance.
    

Eligibility criteria:

        Inclusion Criteria: Subjects must meet all of the following criteria to be considered
        eligible to participate in the study:

          -  be a female between 18 and 70 years of age, inclusive

          -  have a body mass index ≤ 32 kg/m2 and a body weight between 50 and 95 kg, inclusive

          -  be scheduled for a mastectomy with breast reconstruction surgery using an abdominal
             flap technique

          -  for women diagnosed with breast cancer, has standard of care treatment for breast
             cancer prior to surgery and will have standard of care treatment for breast cancer
             after surgery

          -  for subjects of childbearing potential, be surgically sterile or using an insertable,
             injectable, transdermal, or combination oral contraceptive approved by the FDA through
             completion of the study and have negative results on a serum pregnancy test done
             before administration of study medication (women who are postmenopausal [no menses for
             at least 2 years] are also eligible to participate)

          -  be able to understand the study procedures, agree to participate in the study program,
             and voluntarily provide written informed consent

        Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from
        participating in the study:

          -  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