Clinical Trials Directory

Trials / Completed

CompletedNCT04072237

Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia

Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Ascending Doses of Subcutaneous Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Catalyst Biosciences · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without an inhibitor.

Detailed description

This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without an inhibitor. The study will enroll at least 8 adult male subjects with moderate or severe Hemophilia A or B with or without an inhibitor, in each dosing stage. Each subject will receive escalating doses of MarzAA for each stage of the study (except for Stage 5, where subjects receive the same dose as in Stage 4 split between two anatomical sites).

Conditions

Interventions

TypeNameDescription
BIOLOGICALMarzAA (marzeptacog alfa [activated])Single intravenous dose and ascending doses of subcutaneous injection of MarzAA (Coagulation Faction VIIa Variant)

Timeline

Start date
2019-09-24
Primary completion
2020-04-30
Completion
2020-06-17
First posted
2019-08-28
Last updated
2021-09-13
Results posted
2021-07-16

Locations

5 sites across 2 countries: Bulgaria, Russia

Regulatory

Source: ClinicalTrials.gov record NCT04072237. Inclusion in this directory is not an endorsement.