A Study to Investigate the Safety, Tolerability, PK and PD of MG1113 in Healthy Subjects and Hemophilia Patients
NCT ID: NCT03855696
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2019-01-21
2021-08-31
Brief Summary
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Detailed Description
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For healthy subjects, 6 subjects will be assigned to the study group and 2 subjects will be assigned to the placebo group to explore the safety and tolerability, and PK/PD of the study drug in comparison with placebo. Hemophilia patients will be assigned only to the study group with 3 and 6 subjects in each cohort, respectively.
The investigator and subjects will know which cohort the healthy subjects have been assigned to, but they will be double-blinded as to whether the subjects are assigned to the study group (study drug) or the placebo group (placebo) within each cohort.
The doses planned in healthy subjects are 0.5 mg/kg, 1.7 mg/kg, and 3.3 mg/kg by SC injection; 3.3 mg/kg by IV injection. In hemophilia patients, 1.7 mg/kg and 3.3 mg/kg will be administered by SC injection. The planned dose will be administered after checking the safety and tolerability at the previous dose to the extent not exceeding the criteria for discontinuation of dose escalation. The dose escalation will be decided by the Data Monitoring Committee(DMC) and Data and Safety Monitoring Boards (DSMB) in the blinded evaluation of the safety and tolerability data obtained from each previous cohort for 7 days after administration. Before deciding dose escalation and proceeding to the next step, the safety, tolerability, PK, and PD data obtained from all healty subjects and hemophilia patients up to cohort 6 will be evaluated by the Data and Safety Monitoring Boards (DSMB) in an unblinded manner. In addition, if necessary, the analysis result of cohort that has completed all the scheduled visits can be reviewed in an unblinded manner.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
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MG1113
* Anti-tissue factor pathway inhibitor (TFPI) recombinant antibody
* Each vial contains 1mL of study drug
* The doses planned in healthy subjects are 0.5 mg/kg, 1.7 mg/kg, and 3.3 mg/kg by SC injection; 3.3 mg/kg by IV injection. In hemophilia patients, 1.7 mg/kg and 3.3 mg/kg will be administered by SC injection.
MG1113
MG1113
Placebo of MG1113
* Placebo of MG1113
* Each vial contains 1mL of study drug
Placebo of MG1113
Placebo of MG1113
Interventions
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MG1113
MG1113
Placebo of MG1113
Placebo of MG1113
Eligibility Criteria
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Inclusion Criteria
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
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
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\>
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
19 Years
60 Years
MALE
Yes
Sponsors
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Dream CIS, Inc.
INDUSTRY
Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ji-Young Park, MD
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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Yonsei Cancer Center, Yonsei University Severance Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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MG1113_P1
Identifier Type: -
Identifier Source: org_study_id