NXT007_Hemophilia-A_NXT001JG (NXTAGE)

A PHASE I/II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF NXT007 IN HEALTHY VOLUNTEERS AND PATIENTS WITH HEMOPHILIA A (NXTAGE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224835

Enrollment

124

Registered

2019-08-20

Start date

2019-08-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Interventions

investigational material(s) Generic name etc : NXT007 INN of investigational material : zemocimig Therapeutic category code : 634 Human blood preparations Dosage and Administration for Investigational

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: [Healthy volunteer] - Japanese - Age 20 - 44 years, inclusive [Patient] - Severe congenital hemophilia A - Age 12 - 64 years, inclusive - Documented bleeding episodes (bleeding period, bleeding site) and the therapeutic history with blood coagulation factor products for 24 weeks prior to enrollment

Exclusion criteria

Exclusion criteria: [Healthy volunteer] - Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA) [Patient] - Bleeding disorder other than congenital hemophilia A - Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA) - Planned immune tolerance induction (ITI) therapy during the study period

Design outcomes

Primary

Measure	Time frame
safety efficacy pharmacokinetics pharmacodynamics Safety, efficacy, phamacodynamics, pharmacokinetics	—

Secondary

Measure	Time frame
other Immunogenecity	—

Countries

Japan, Korea, Taiwan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026