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HemophiliaPhase 1NCT03855696

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

A Phase 1 study testing MG1113 in people with Hemophilia, run by Green Cross Corporation at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 19 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hemophilia
What is being tested?
MG1113
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
2 sitesSouth Korea
Study dates
21 Jan 2019to 31 Aug 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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)
Show all 35Show fewer
  • 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>
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Yonsei Cancer Center, Yonsei University Severance Hospital

    Seoul, 120-752

  • Korea University Anam Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase I, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MG1113 in Healthy Subjects and Hemophilia Patients

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.

Conditions
Hemophilia
Being tested
MG1113, Placebo of MG1113
Keywords
MG1113, Hemophilia
Medical subject headings
Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MG1113Biological

    MG1113

  • Placebo of MG1113Other

    Placebo of MG1113

Study groups in NCT03855696
Study groupRoleWhat they receive
MG1113Experimental* 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.
Receives: Biological: MG1113
Placebo of MG1113Placebo comparator* Placebo of MG1113 * Each vial contains 1mL of study drug
Receives: Other: Placebo of MG1113

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Adverse events such as subjective and objective symptoms

    Measured: Through study completion (~50 day)

Secondary outcomes (24)

  1. Immunogenicity assay

    ADA [Anti-Drug Ab]

    Measured: Through study completion (~50 day)

  2. Pharmacokinetic assessment - Cmax

    Cmax

    Measured: Through study completion (~50 day)

  3. Pharmacokinetic assessment - Tmax

    Tmax

    Measured: Through study completion (~50 day)

  4. Pharmacokinetic assessment - AUClast

    AUClast

    Measured: Through study completion (~50 day)

  5. Pharmacokinetic assessment - AUCinf

    AUCinf

    Measured: Through study completion (~50 day)

  6. Pharmacokinetic assessment - half-life

    half-life

    Measured: Through study completion (~50 day)

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

    CL/F (for SC)

    Measured: Through study completion (~50 day)

  8. Pharmacokinetic assessment - CL (for IV)

    CL (for IV)

    Measured: Through study completion (~50 day)

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

    Vd/F (for SC)

    Measured: Through study completion (~50 day)

  10. Pharmacokinetic assessment - Vd (for IV)

    Vd (for IV)

    Measured: 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])

    Measured: Through study completion (~50 day)

  12. Pharmacodynamic assessment - Free TFPI in plasma

    Free TFPI in plasma (ng/mL)

    Measured: Through study completion (~50 day)

  13. Pharmacodynamic assessment - Diluted PT

    Diluted PT (sec)

    Measured: Through study completion (~50 day)

  14. Pharmacodynamic assessment - residual TFPI activity

    residual TFPI activity

    Measured: Through study completion (~50 day)

  15. Pharmacodynamic assessment - Thrombin generation

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

    Measured: Through study completion (~50 day)

  16. Pharmacodynamic assessment - Pro-coagulant effect

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

    Measured: Through study completion (~50 day)

  17. Physical examination

    Physical examination

    Measured: 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

    Measured: Through study completion (~50 day)

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

    Vital signs - blood pressure (Systolic, Diastolic)

    Measured: Through study completion (~50 day)

  20. Vital signs - pulse rate

    Vital signs - pulse rate

    Measured: Through study completion (~50 day)

  21. Vital signs - body temperature

    Vital signs - body temperature

    Measured: 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)

    Measured: 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).

    Measured: 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 103/mcL,Neutrophils in %,ANC in mcL,Lymphosyte in %,Monocyte in %,Eosinophils in %,Basophils in %,RBC in 106/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%)

    Measured: Through study completion (~50 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2019
  2. Study start21 Jan 2019
  3. Primary completion30 Jun 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential dose escalation model
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03855696
Sponsor's protocol ID
MG1113_P1
Status last verified
Oct 2021
First submitted
12 Feb 2019
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MG1113 in people with Hemophilia, run by Green Cross Corporation at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Through study completion (~50 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03855696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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