Subcutaneous Elafin in Healthy Subjects

You may be eligible if

• A subject will be eligible only if all of the following criteria apply:
• 1. Male or female, 18 - 55 years of age
• 2. No history or clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health at screening examination.
• 3. Normal or clinically acceptable ECG
• 4. Normal blood pressure (systolic: 90 - 140 mmHg; diastolic: 50 - 90 mmHg) and heart rate (45 - 100 bpm)
• 5. Body mass index of 18.0 - 32.0 (kg/m2)
• 6. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
• 7. Informed consent.
• 8. Females of childbearing potential must use an acceptable form of contraception at time of enrollment (and throughout the duration of study) including, but not limited to the following:
• 1. Documentation of surgical sterilization (bilateral tubal ligation, hysterectomy)
• 2. Naturally postmenopausal (spontaneous cessation of menses) for at least 24 consecutive months prior to dosing on Day -1 and with an FSH level at screening of ≥ 40 mIU/mL
• 3. Intrauterine Device (IUD) plus condom plus contraceptive sponge or foam or jelly
• 4. Condom plus contraceptive sponge or foam or jelly
• 5. Hormonal contraception (combination oral contraceptives, transdermal patch, injectables, implantables, or vaginal ring) \*Subject is not of childbearing potential if the following criteria have been met:
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• 1. Hysterectomy \> 1 month ago
• 2. Bilateral oophorectomy \> 1 month ago
• 3. 45-50 years old AND LMP ≥ 24 months ago and documented FSH \> 40mIU/mL
• 9. Males must agree to use a barrier method of birth control from 30 days before first study drug administration until 90 days after last study drug administration.
• 1. Administration of any investigational drug 45 days prior to study enrollment.
• 2. Active participation in another interventional clinical trial.
• 3. Use of any prescription medication within 30 days (with exception to oral contraceptives) or over-the-counter medication (OTC) within 7 days before first study drug administration. Use of OTC medications may be permitted after day 1 visit until end of study with approval of the protocol investigator.
• 4. Subject performed heavy physical exertion 2 days before eligibility assessment and before admission into clinical research center.
• 5. Subject consumes more than 500 mL of beer/day or 250 mL of wine/day or 2 glasses of liquor/day.
• 6. Subject has a history of chronic alcohol or drug abuse within the last 4 weeks.
• 7. Subject smokes more than 10 cigarettes per day or has done so within 6 months prior to eligibility assessment.
• 8. Subject has a diet that deviates notably from the "normal" amounts of protein, carbohydrate, and fat, as judged by the investigator (e.g., vegetarians or vegans).
• 9. Subject consumes more than 600 mg of caffeine/day (200 mL of coffee contain approximately 100 mg of caffeine, 200 mL of black tea approximately 30 mg and 200 mL of soda approximately 20 mg).
• 10. Subject has donated blood or had a comparable blood loss (\>400 mL) within the last 3 months prior to eligibility assessment or anemia defined by hematocrit value less than 30% at screening.
• 11. Subject has any clinically relevant abnormality in physical examination, vital signs and electrocardiogram (ECG).
• 12. Serious adverse reaction or hypersensitivity to any drug.
• 13. Inability to communicate or co-operate due to a language problem, poor mental development or impaired cerebral function.
• 14. Females who are lactating or at risk of pregnancy.
• 15. Presence of pain incurred by unknown causes.
• 16. History of asthma or other respiratory disease.
• 17. History of neurologic or neuromuscular disease.
• 18. History of hypotension, hypertension or cardiovascular disease.
• 19. History of gastrointestinal, hepatic, or renal disease and/or impairment.
• 20. Positive urine drug screen for drugs with a high potential for abuse and low persistence in the urine.
• 21. Subject with active or history of malignancy, known Hepatitis B or C, or HIV.