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).
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%.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
Royal London Hospital
London, United Kingdom
RECRUITINGIncidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)
Time frame: Baseline through Day 57
Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf)
Time frame: Day 1 through Day 57
Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2)
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Total Factor VII
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Factor VII Activity
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Prothrombin time (PT) Measurement
Time frame: Day 1 through Day 57
Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement
Time frame: Day 1 through Day 57
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Anti-drug antibody levels
Time frame: Day 1 through Day 57