A Study to Investigate the Safety, Tolerability, PK and PD of MG1113 in Healthy Subjects and Hemophilia Patients

This is an interventional prevention trial for Hemophilia focused on measuring MG1113, Hemophilia Read More

<Healthy adult subjects>

• Inclusion Criteria:

  1. Healthy male adult subjects aged 19-60 years (both inclusive) at screening
  2. 50 to 90 kg in weight with calculated BMI between 18.5 and 29.9 kg/m2
  3. Agree to use medically acceptable adequate dual contraceptive methods (condom, vasectomy, spermicide, oral contraceptives, intrauterine device, and complete sexual abstinence, etc.) and not to donate sperm until 3 months after administration of the investigational product
  4. Voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a detailed explanation on this study and fully understanding the information

• Exclusion Criteria:

  1. Presence or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immune, skin, nervous, or psychiatric disease
  2. Symptoms of acute disease within 28 days of investigational product administration
  3. Medical history that may affect absorption, distribution, metabolism and excretion of drugs
  4. Clinically significant active chronic disease
  5. Clinically significant allergic disease (however, mild allergic rhinitis or allergic dermatitis not requiring any medication is allowed) or history of any anaphylactic reaction
  6. Any of the following results from laboratory tests: 1) AST (sGOT) or ALT (sGPT) >2 x UNL 2) Hb < 9.0 g/dL 3) Absolute Neutrophil Count < 1500 mm2 4) Platelet count < 100 x 103 mm2 5) aPTT, PT > 1.5 x UNL 6) Have hepatitis B (HBsAg positive) or C (anti-HCV positive), or have positive HIV test result 7) Creatinine clearance ≤80 mL/min (calculated by the Cockcroft-Gault formula)
  7. Have a family history or be considered to be at risk of thromboembolic events, or have the following test results: 1) Antithrombin level ≤LNL 2) Protein C or S activity ≤LNL 3) Factor V Leiden mutation 4) Prothrombin G20210A mutation
  8. Used ethical drugs including prescription drugs within 14 days of investigational product administration
  9. Used drugs (over-the-counter drugs, herbal medicines, and nutritional agents and vitamins for the purpose of same efficacy) within 7 days of investigational product administration
  10. Cannot have standard meals provided at the hospital
  11. Donated whole blood within 60 days of investigational product administration, or donated blood components within 20 days of investigational product administration, or received blood transfusion within 1 month before administration
  12. Participated in another clinical trial or bioequivalence study within 90 days of investigational product administration (If participating in a clinical trial after 12/06/2019, not within 90 days, but within 6 months is applied)
  13. Individuals who consume caffeine (caffeine >5 cups/day) or alcohol (alcohol >30 g/day) continuously, who cannot abstain from drinking during the study, or heavy smoker (>10 cigarettes/day)
  14. Determined to be ineligible to participate in the study per investigator's judgment due to other reasons including the laboratory test results
  15. History of drug abuse or positive urine drug screen results

<Hemophilia patients>

• Inclusion criteria

  1. Male hemophilia A or B patients aged 19-60 years (both inclusive) at screening
  2. ≥50 kg in weight with calculated BMI between 18.5 and 29.9 kg/m2
  3. Agree to use medically acceptable adequate dual contraceptive methods (condom, vasectomy, spermicide, oral contraceptives, intrauterine device, and complete sexual abstinence, etc.) and not to donate sperm until 60 days after administration of the investigational product
  4. Voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a detailed explanation on this study and fully understanding the information

• Exclusion criteria

  1. Symptoms of acute disease within 28 days of investigational product administration or any surgery planned during the study period
  2. Medical history that may affect absorption, distribution, metabolism and excretion of drugs
  3. Clinically significant active chronic disease
  4. Clinically significant allergic disease (however, mild allergic rhinitis or allergic dermatitis not requiring any medication is allowed) or history of any anaphylactic reaction
  5. Patients having current human factor VIII or IX with an inhibitor titer of >5 Bethesda units or patients requiring treatment with bypassing agent
  6. Patients who has a history of confirmed human factor VIII or IX with an inhibitor titer of >5 Bethesda units at any time
  7. History of ≥6 bleeding episodes despite temporary bypassing agent administered for 24 weeks before screening, or ≥2 bleeding episodes despite the bypassing agent administered prophylactically
  8. Received factor VIII or factor IX within 48 hours prior to administration of the investigational product
  9. Hemostatic agent, etc. prescribed to control bleeding within 5 days prior to administration of the investigational product
  10. Immune tolerance induction prescribed within 30 days prior to administration of the investigational product
  11. Currently using systemic immunomodulator (e.g., interferon or rituximab)
  12. Be at risk of thrombotic microangiopathy per investigator's judgment or have related medical history or family history
  13. Congenital or acquired anticoagulant disorders other than hemophilia A or B, or conditions of other diseases that increase the risk of bleeding or thrombus (e.g., autoimmune disease)
  14. Any of the following results from laboratory tests: 1) AST (sGOT) or ALT (sGPT) >3 x UNL 2) Hb < 9.0 g/dL 3) Absolute Neutrophil Count < 1500 mm2 4) Platelet count < 100 x 103 mm2 5) Have hepatitis B (HBs Ag positive) or C (anti-HCV positive), or have HIV positive test result 6) Creatinine clearance ≤80 mL/min (calculated by the Cockcroft-Gault formula)
  15. Cannot have standard meals provided at the hospital
  16. Participated in another clinical trial within 90 days of investigational product administration
  17. Individuals who consume caffeine (caffeine >5 cups/day) or alcohol (alcohol >30 g/day) continuously, who cannot abstain from drinking during the study, or heavy smoker (>10 cigarettes/day)
  18. Determined to be ineligible to participate in the study per investigator's judgment due to other reasons including the laboratory test results
  19. History of drug abuse or positive urine drug screen results