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CompletedNCT03855696Updated Oct 26, 2021

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

A Phase 1 interventional study of MG1113 and Placebo of MG1113 in Hemophilia, sponsored by Green Cross Corporation. Completed at 2 sites in Korea, Republic of. Open to male participants aged 19 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by Green Cross Corporation · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
Male
01

Study summary

The purpose of this study is to assess the safety and tolerability of MG1113 in the single ascending dose study (IV injection or SC injection) in healthy subjects and hemophiia patients.

Read the detailed description

This is a single-dose study that explore the safety, tolerability, PK, and PD of the study drug by sequentially increasing the study drug in 4 dose levels. The route of administration is either subcutaneous (SC) injection or intravenous (IV) injection.

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.

02

Conditions studied

  • Hemophilia

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Keywords

  • MG1113
  • Hemophilia
03

In context

Hemophilia A

844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.

This study's enrollment of 41 is above the median of 30 across 499 interventional studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Green Cross Corporation is the lead sponsor of 63 studies on the registry; 1 is open to participants now.

Browse GC Biopharma Corp. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

\<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 between 18.5 and 29.9 kg/m2
    3. Agree to use medically acceptable adequate dual 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 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 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) (sGOT) or ALT (sGPT) >2 x UNL 2) \< 9.0 g/dL 3) \< 1500 mm2 4) count \< 100 x 103 mm2 5) , PT > 1.5 x UNL 6) Have (HBsAg positive) or C (anti- positive), or have positive test result 7) ≤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., 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
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    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.

    Biological: MG1113

  • Placebo comparator
    Placebo of MG1113

    * Placebo of MG1113 * Each vial contains 1mL of study drug

    Other: Placebo of MG1113

Interventions

  • BiologicalMG1113

    MG1113

  • OtherPlacebo of MG1113

    Placebo of MG1113

06

What researchers measure

Primary outcomes

  1. Adverse events

    Adverse events such as subjective and objective symptoms

    Time frame: Through study completion (~50 day)

Secondary outcomes

  1. Immunogenicity assay

    ADA \[Anti-Drug Ab\]

    Time frame: Through study completion (~50 day)

  2. Pharmacokinetic assessment - Cmax

    Cmax

    Time frame: Through study completion (~50 day)

  3. Pharmacokinetic assessment - Tmax

    Tmax

    Time frame: Through study completion (~50 day)

  4. Pharmacokinetic assessment - AUClast

    AUClast

    Time frame: Through study completion (~50 day)

  5. Pharmacokinetic assessment - AUCinf

    AUCinf

    Time frame: Through study completion (~50 day)

  6. Pharmacokinetic assessment - half-life

    half-life

    Time frame: Through study completion (~50 day)

  7. Pharmacokinetic assessment - CL/F (for SC)

    CL/F (for SC)

    Time frame: Through study completion (~50 day)

  8. Pharmacokinetic assessment - CL (for IV)

    CL (for IV)

    Time frame: Through study completion (~50 day)

  9. Pharmacokinetic assessment - Vd/F (for SC)

    Vd/F (for SC)

    Time frame: Through study completion (~50 day)

  10. Pharmacokinetic assessment - Vd (for IV)

    Vd (for IV)

    Time frame: Through study completion (~50 day)

  11. Pharmacokinetic assessment - Bioavailability (F)

    Bioavailability (F) Bioavailability (F) = AUCinf (at SC dosing \[3.3 mg/kg\])/AUCinf (at IV dosing \[3.3 mg/kg\])

    Time frame: Through study completion (~50 day)

  12. Pharmacodynamic assessment - Free TFPI in plasma

    Free TFPI in plasma (ng/mL)

    Time frame: Through study completion (~50 day)

  13. Pharmacodynamic assessment - Diluted PT

    Diluted PT (sec)

    Time frame: Through study completion (~50 day)

  14. Pharmacodynamic assessment - residual TFPI activity

    residual TFPI activity

    Time frame: Through study completion (~50 day)

  15. Pharmacodynamic assessment - Thrombin generation

    Thrombin generation (lag time, peak generation, Endogenous thrombin generation potential \[ETP\])

    Time frame: Through study completion (~50 day)

  16. Pharmacodynamic assessment - Pro-coagulant effect

    Pro-coagulant effect (D-dimer, Fibrinogen, prothrombin fragments 1+2)

    Time frame: Through study completion (~50 day)

  17. Physical examination

    Physical examination

    Time frame: Through study completion (~50 day)

  18. Incidence of participant abnormalities in 12-lead ECG (Ventricular rate in beat/min, Interval for PR in msec, QRS in msec, QTc in msec) for physiological parameter

    The result for 12-lead ECG will be reported as Clinical Significant or Not-Clinical Significant. * Ventricular rate in beat/min * Interval for PR in msec * QRS in msec * QTc in msec

    Time frame: Through study completion (~50 day)

  19. Vital signs - blood pressure (Systolic, Diastolic)

    Vital signs - blood pressure (Systolic, Diastolic)

    Time frame: Through study completion (~50 day)

  20. Vital signs - pulse rate

    Vital signs - pulse rate

    Time frame: Through study completion (~50 day)

  21. Vital signs - body temperature

    Vital signs - body temperature

    Time frame: Through study completion (~50 day)

  22. Frequency of Bleeding (only for hemophilia patients)

    Bleeding evaluation (only for hemophilia patients) by questionnaire; Occurrence date, Persistence in yes or no questionnaire, Causes (blood in naturally occurring/Traumatic bleeding), Severity (mild/moderate/Severe)

    Time frame: Through study completion (~50 day)

  23. Local reaction in injection site

    Pain or tenderness, itching, rash, redness (in mm), and induration (in mm) will be reported. Local stimulation test in injection site: Occurrence date, Persistence, Causes, Severity (mild/moderate/Severe) The occurrence of pain or tenderness, itching and rash will be reported by Yes or No questionnaire. The size of redness and induration will be measured in millmeters(mm).

    Time frame: Through study completion (~50 day)

  24. Incidence of participant abnormalities in laboratory tests by physiological parameter (Hematology, clinical chemistry, urinalysis, and blood coagulation test)

    Parameters for laboratory tests include Hematology(WBC in 10\*\*3/mcL,Neutrophils in %,ANC in mcL,Lymphosyte in %,Monocyte in %,Eosinophils in %,Basophils in %,RBC in 10\*\*6/mcL,Hemoglobin in g/dL,Hematocrit in %,MCV in fL, MCH in pg,MCHC in g/dL,Platelets in 10\*\*3/mcL,MPV in fL),Clinical chemistry(Glucose in mg/dL,BUN in mg/dL,Uric adic in mg/dL,Total cholesterol in mg/dL,Triglyceride in mg/dL,Protein,Albumin in g/dL,Total bilirubin in mg/dL,Alkaline phosphatase in IU/L,AST in IU/L,ALT in IU/L,r-GT in IU/L,LDH in IU/L,Serum creatinine in mg/dL,Na in mmol/L,K in mmol/L,Cl in mmol/L,CPK in IU/L,Troponin I in ng/mL,Troponin T in ng/mL,Creatinine Clearance),Urinalysis(These values are reported only as a number;Specific garavity,Color,pH,Protein,Glucose,Ketone,Bilirubin,Blood,Urobilinogen,Nitrite,WBC,Squma EP cell,Casts,Crystal,Clarity,RBC),Blood coagulation test (aPTT in sec,PT in sec,Fibronogen in mg/dL,Antithrombon III in %,Protein C in %,Protein S in%)

    Time frame: Through study completion (~50 day)

07

Study locations

2 sites
  • Yonsei Cancer Center, Yonsei University Severance Hospital
    Seoul, 120-752, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Jun 2021, 29 months.

Of 37 industry-sponsored phase 1 interventional studies under Hemophilia A, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 29 months is above that.

Counting every sponsor, half of 46 studies reached it within 13 months; a quarter within 7 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2019
First posted
Feb 27, 2019
StartActual
Jan 21, 2019
Primary completionActual
Jun 30, 2021
CompletionActual
Aug 31, 2021
Last update
Oct 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03855696
Lead sponsor
Green Cross Corporation
Collaborators
Dream CIS, Inc.
Responsible party
Sponsor
First posted
Feb 27, 2019
Start date
Jan 21, 2019
Primary completion
Jun 30, 2021
Completion
Aug 31, 2021
Last update
Oct 26, 2021

Study contacts

Ji-Young Park, MD
principal investigator · Korea University Anam Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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