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Report for Clinical Trial NCT03855696

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT03855696 Hemophilia
MeSH:Hemophilia A
HPO:Reduced factor VIII activity

2 Interventions

Name: MG1113

Description: MG1113
Type: Biological
Group Labels: 1

MG1113

Name: Placebo of MG1113

Description: Placebo of MG1113
Type: Other
Group Labels: 1

Placebo of MG1113


Primary Outcomes

Description: Adverse events such as subjective and objective symptoms

Measure: Adverse events

Time: Through study completion (~50 day)

Secondary Outcomes

Description: ADA [Anti-Drug Ab]

Measure: Immunogenicity assay

Time: Through study completion (~50 day)

Description: Cmax

Measure: Pharmacokinetic assessment - Cmax

Time: Through study completion (~50 day)

Description: Tmax

Measure: Pharmacokinetic assessment - Tmax

Time: Through study completion (~50 day)

Description: AUClast

Measure: Pharmacokinetic assessment - AUClast

Time: Through study completion (~50 day)

Description: AUCinf

Measure: Pharmacokinetic assessment - AUCinf

Time: Through study completion (~50 day)

Description: half-life

Measure: Pharmacokinetic assessment - half-life

Time: Through study completion (~50 day)

Description: CL/F (for SC)

Measure: Pharmacokinetic assessment - CL/F (for SC)

Time: Through study completion (~50 day)

Description: CL (for IV)

Measure: Pharmacokinetic assessment - CL (for IV)

Time: Through study completion (~50 day)

Description: Vd/F (for SC)

Measure: Pharmacokinetic assessment - Vd/F (for SC)

Time: Through study completion (~50 day)

Description: Vd (for IV)

Measure: Pharmacokinetic assessment - Vd (for IV)

Time: Through study completion (~50 day)

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

Measure: Pharmacokinetic assessment - Bioavailability (F)

Time: Through study completion (~50 day)

Description: Free TFPI in plasma (ng/mL)

Measure: Pharmacodynamic assessment - Free TFPI in plasma

Time: Through study completion (~50 day)

Description: Diluted PT (sec)

Measure: Pharmacodynamic assessment - Diluted PT

Time: Through study completion (~50 day)

Description: FXa activity

Measure: Pharmacodynamic assessment - FXa activity

Time: Through study completion (~50 day)

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

Measure: Pharmacodynamic assessment - Thrombin generation

Time: Through study completion (~50 day)

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

Measure: Pharmacodynamic assessment - Pro-coagulant effect

Time: Through study completion (~50 day)

Description: Physical examination

Measure: Physical examination

Time: Through study completion (~50 day)

Description: 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

Measure: 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

Time: Through study completion (~50 day)

Description: Vital signs - blood pressure (Systolic, Diastolic)

Measure: Vital signs - blood pressure (Systolic, Diastolic)

Time: Through study completion (~50 day)

Description: Vital signs - pulse rate

Measure: Vital signs - pulse rate

Time: Through study completion (~50 day)

Description: Vital signs - body temperature

Measure: Vital signs - body temperature

Time: Through study completion (~50 day)

Description: 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)

Measure: Frequency of Bleeding (only for hemophilia patients)

Time: Through study completion (~50 day)

Description: 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).

Measure: Local reaction in injection site

Time: Through study completion (~50 day)

Description: 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, MCHin pg, MCHC in g/dL, Plstelets 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), 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 %)

Measure: Incidence of participant abnormalities in laboratory tests by physiological parameter (Hematology, clinical chemistry, urinalysis, and blood)

Time: Through study completion (~50 day)

Purpose: Prevention

Allocation: Randomized

Sequential Assignment


There is one SNP

SNPs


1 G20210A

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. --- G20210A ---



HPO Nodes


HPO: