Clinical Drug Experience Knowledgebase

Criteria

<Healthy adult subjects>

Inclusion Criteria:

Healthy male adult subjects aged 19-60 years (both inclusive) at screening
50 to 90 kg in weight with calculated BMI between 18.5 and 29.9 kg/m2
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
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:

Presence or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immune, skin, nervous, or psychiatric disease
Symptoms of acute disease within 28 days of investigational product administration
Medical history that may affect absorption, distribution, metabolism and excretion of drugs
Clinically significant active chronic disease
Clinically significant allergic disease (however, mild allergic rhinitis or allergic dermatitis not requiring any medication is allowed) or history of any anaphylactic reaction
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)
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
Used ethical drugs including prescription drugs within 14 days of investigational product administration
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
Cannot have standard meals provided at the hospital
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
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)
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)
Determined to be ineligible to participate in the study per investigator's judgment due to other reasons including the laboratory test results
History of drug abuse or positive urine drug screen results

<Hemophilia patients>

Inclusion criteria

Male hemophilia A or B patients aged 19-60 years (both inclusive) at screening
≥50 kg in weight with calculated BMI between 18.5 and 29.9 kg/m2
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
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

Symptoms of acute disease within 28 days of investigational product administration or any surgery planned during the study period
Medical history that may affect absorption, distribution, metabolism and excretion of drugs
Clinically significant active chronic disease
Clinically significant allergic disease (however, mild allergic rhinitis or allergic dermatitis not requiring any medication is allowed) or history of any anaphylactic reaction
Patients having current human factor VIII or IX with an inhibitor titer of >5 Bethesda units or patients requiring treatment with bypassing agent
Patients who has a history of confirmed human factor VIII or IX with an inhibitor titer of >5 Bethesda units at any time
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
Received factor VIII or factor IX within 48 hours prior to administration of the investigational product
Hemostatic agent, etc. prescribed to control bleeding within 5 days prior to administration of the investigational product
Immune tolerance induction prescribed within 30 days prior to administration of the investigational product
Currently using systemic immunomodulator (e.g., interferon or rituximab)
Be at risk of thrombotic microangiopathy per investigator's judgment or have related medical history or family history
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)
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)
Cannot have standard meals provided at the hospital
Participated in another clinical trial within 90 days of investigational product administration
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)
Determined to be ineligible to participate in the study per investigator's judgment due to other reasons including the laboratory test results
History of drug abuse or positive urine drug screen results