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ArticleResearch and practice in thrombosis and haemostasis2026

Subcutaneous MG1113 in severe hemophilia A and B: phase 1b study for safety, pharmacokinetics, and pharmacodynamics.

Chur-Woo You, Hee Jo Baek, Young-Shil Park, Bo Ram Kim, Hayoung Lee, Seon Hui Kim, Sung Ho Hwang, Eun Jin Choi

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05493631 (A Phase 1b, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous MG1113 in Patients With Severe Hemophilia), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05493631 phase1completednot on this map

A Phase 1b, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous MG1113 in Patients With Severe Hemophilia

TypeinterventionalSponsorGC Biopharma CorpRan2022 to 2024Enrolled15ConditionsHemophiliaArmsMG1113
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Chur-Woo YouDepartment of Pediatrics, Eulji University School of Medicine, Seoul, Republic of Korea.
Hee Jo BaekDepartment of Pediatrics, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.
Young-Shil ParkDepartment of Pediatrics, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.
Bo Ram KimDepartment of Pediatrics, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.
Hayoung LeeMedical Division, GC Biopharma, Yongin, Republic of Korea.
Seon Hui KimMedical Division, GC Biopharma, Yongin, Republic of Korea.
Sung Ho HwangMedical Division, GC Biopharma, Yongin, Republic of Korea.
Eun Jin ChoiDepartment of Pediatrics, Daegu Catholic University School of Medicine, Daegu, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: MG1113 is an immunoglobulin G4 monoclonal antibody targeting the Kunitz-2 domain of tissue factor pathway inhibitor (TFPI), developed as a hemostatic rebalancing agent for patients with hemophilia A or B. Objectives: We aimed to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary hemostatic effects of MG1113. Methods: This phase 1b clinical trial was conducted in a multicenter, prospective, stepwise dose-escalating (2.0, 3.0, and 3.3 mg/kg) design. MG1113 was administered subcutaneously once weekly for 8 weeks. Results: Fifteen male patients ( Conclusion: MG1113, administered subcutaneously as a prophylaxis in patients with severe hemophilia A or B without inhibitors for 8 weeks, demonstrated an acceptable safety profile with a PK profile suitable for once-a-week dosing. The pharmacodynamics marker changes were consistent with TFPI inhibition, which was associated with reductions in bleeding events. Trial registration: This trial was prospectively registered at www.ClinicalTrials.gov (#NCT05493631).

Indexed as

Hemophilia AHemophilia BHemostaticsAdolescentAdultDose-Response Relationship, DrugHemorrhageHumansInjections, SubcutaneousLipoproteinsMaleMiddle AgedProspective StudiesProthrombin TimeTreatment OutcomeYoung AdultHemostaticslipoprotein-associated coagulation inhibitorLipoproteinsefficacyhemophiliapharmacodynamicspharmacokineticssafetytissue factor pathway

Identifiers

PMID42757060
PMCPMC13584034

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