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

NCT03855696 | Completed Phase 1 DMC

• 1 other identifier: MG1113_P1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hemophilia

Keywords

MG1113; Hemophilia

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events such as subjective and objective symptoms

  Through study completion (~50 day)

Secondary Outcomes (24)

• Immunogenicity assay

  Through study completion (~50 day)

• Pharmacokinetic assessment - Cmax

  Through study completion (~50 day)

• Pharmacokinetic assessment - Tmax

  Through study completion (~50 day)

• Pharmacokinetic assessment - AUClast

  Through study completion (~50 day)

• Pharmacokinetic assessment - AUCinf

  Through study completion (~50 day)

Study Arms (2)

MG1113

EXPERIMENTAL

* 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 of MG1113

PLACEBO COMPARATOR

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

Other: Placebo of MG1113

Interventions

MG1113 BIOLOGICAL

MG1113

MG1113

Placebo of MG1113 OTHER

Placebo of MG1113

Placebo of MG1113

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male adult subjects aged 19-60 years (both inclusive) at screening
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Corporation: lead
• Dream CIS, Inc.: collaborator

Study Sites (2)

Yonsei Cancer Center, Yonsei University Severance Hospital

Seoul, 120-752, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ji-Young Park, MD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential dose escalation model

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 27, 2019
• Study Start: January 21, 2019
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)