Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects

Inclusion Criteria

• Healthy, adult, male and/or female (females of non-childbearing potential only), 18 to 55 years of age, inclusive, at screening.
• Continuous non-smoker, who has not used nicotine-containing products for at least 3 months prior to dosing, based on subject self-reporting.
• Body mass index (BMI) ≥ 18 and 450 msec for males or > 460 msec for females, or history of prolonged QT syndrome at screening.
• Estimated creatinine clearance < 90 mL/minutes at screening using the Cockcroft Gault estimation.
• Unable to refrain from or anticipates the use of:
• Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning approximately 14 days prior to dosing and throughout the study.
• Any oral or injectable anticoagulant (e.g., warfarin, heparin, low molecular weight heparin, etc.), coagulants (aprotinin, tranexamic acid, epsilon-aminocaproic acid, and aminomethylbenzoic acid), anti-platelet (e.g., clopidogrel), nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetylsalicylic acid (ASA) beginning approximately 10 days prior to dosing and throughout the study.
• Any drugs known to be significant inducers of cytochrome P-450 enzymes and/or P glycoprotein, including St. John's Wort, for 28 days prior to dosing and throughout the study.

Appropriate sources (e.g., Flockhart TableTM) will be consulted to confirm lack of pharmacokinetic/ pharmacodynamic interaction with study medication. Acetaminophen (up to 2 g per 24 hour period) or any other treatment of an adverse event, drug related or not, and considered appropriate and allowable by the PI or designee may be permitted after dosing.

• Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to dosing and throughout the study.
• Has participated in strenuous exercise or physical activity within 72 hours prior to Day 1, unless deemed acceptable by the PI or designee.
• Donation of blood or significant blood loss within 56 days prior to dosing.
• Plasma donation within 7 days prior to dosing.
• Has been hospitalized within 2 months of Day -1.
• Participation in another clinical study within 30 days prior to dosing. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
• Surgery within the past 90 days prior to dosing which in the opinion of the PI or designee is clinically relevant.
• Presence of any scars, or tattoos which may obscure the injection site, as deemed by PI or designee.
• Any condition or circumstance, in the opinion of the PI or designee, which may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety.