NCT07347249

A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency

A Clinical Study to Assess the Safety and Efficacy of Sutacimig in Participants With Congenital Factor VII Deficiency

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hemab ApS · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of sutacimig monotherapy in participants with congenital FVII deficiency (FVIID).

Detailed description

The objective is to administer a single dose of sutacimig and to evaluate safety, pharmacokinetics, and pharmacodynamics. Two cohorts may be evaluated. Cohort A is defined by participants with a FVII(a) level of \< 10%. Cohort B is defined by participants with a FVII(a) level of ≥10%.

Conditions

• Congenital Factor VII Deficiency

Interventions

Type	Name	Description
DRUG	Sutacimig	Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
DRUG	Sutacimig	Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-01-16
• Last updated: 2026-01-30

Locations

1 site across 1 country: United Kingdom