Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers
Condition: Healthy
Intervention: 3K3A-APC, diluted in 0.9% sodium chloride in water; 0.9% NaCl in water
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: APC, 3K3A, 3K3A-APC, volunteer, healthy

Summary:

      The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and
      multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males or non-pregnant, non-lactating females

          2. Both men and women of child-bearing potential (i.e., not surgically sterile or
             post-menopausal defined as age > 40 years without menses for ≥ 2 years) must agree to
             use a barrier method of contraception plus a spermicide throughout the study.

          3. Age 18 to 55 years, inclusive

          4. Body Mass Index (BMI) of 19 to 30 kg/m2, inclusive (see APPENDIX B)

          5. Willing and able to complete all study visits

          6. Agreement to abstain from smoking and drinking alcoholic beverages from 48 hours prior
             to randomization through last Study Day (15)

          7. Signed informed consent form (ICF)

        Exclusion Criteria:

          1. Any medical problem for which the subject is being evaluated and/or treated

          2. Activated partial thromboplastin time (aPTT) greater than upper limit of normal (ULN)

          3. Platelet count < 125,000 cells/mm3

          4. International Normalized Ratio (INR) > 1.3

          5. Any other clinically significant abnormalities in laboratory values (chemistries,
             hematology, coagulation studies, and urinalysis - see APPENDIX C)

          6. Clinically significant abnormalities on electrocardiogram (ECG)

          7. Positive serum βHCG pregnancy test at screening or on Study Day -1 (for all women,
             regardless of child-bearing potential)

          8. Positive urine drug screen at screening or on Study Day -1 (see APPENDIX C)

          9. Positive blood test for hepatitis B surface antigen, hepatitis C antibody, or HIV
             antibody

         10. Known family history of bleeding or blood clotting disorders

         11. History of bleeding diathesis

         12. History of liver disease with ongoing coagulopathy

         13. Use of any prescription or non-prescription medications or supplements within 7 days
             prior to Study Day -1, excluding hormonal contraceptives

         14. Use of anticoagulant medication within 14 days prior to Study Day -1

         15. Major surgery within 60 days prior to Study Day -1

         16. Receipt of an investigational drug within 30 days prior to Study Day -1

         17. Donation of blood or plasma within 30 days prior to Study Day -1

         18. Any other condition, that in the opinion of the Site Investigator, may adversely
             affect the safety of the subject, the subject's ability to complete the study, or the
             outcome of the study