A Phase 1/2a, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) Profile of a Long Acting Recombinant FVIIa (MOD-5014) in Adult Men With Hemophilia A or B
Status: Completed
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open label, dose-escalating study. Each dose cohort will be concluded by a safety review, following which escalation to the next dose cohort will be approved.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of moderate or severe congenital Hemophilia A or B with or without inhibitors
Locations
United States
California
City of Hope
Duarte
Children's Hospital Los Angeles
Los Angeles
Orthopaedic Hemophilia Treatment Center
Los Angeles
University of California Davis Medical Center
Sacramento
Illinois
Rush University Medical Center
Chicago
Bleeding & Clotting Disorders Institute
Peoria
Indiana
Indiana Hemophilia & Thrombosis Center
Indianapolis
Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey
UPMC Presbyterian Shadyside
Pittsburgh
Texas
UT Southwestern Medical Center
Dallas
The Gulf States Hemophilia and Thrombophilia Center
Houston
Time Frame
Start Date: 2015-05
Completion Date: 2018-09
Participants
Target number of participants: 27
Treatments
Experimental: Dose Cohort 1
Lowest MOD-5014 dose tested in the study
Experimental: Dose Cohort 2
MOD-5014 Dose cohort 2
Experimental: Dose Cohort 3
MOD-5014 Dose cohort 3
Experimental: Dose Cohort 4
MOD-5014 Dose cohort 4
Experimental: Dose Cohort 5
MOD-5014 Dose cohort 5
Experimental: Dose Cohort 6
Highest MOD-5014 dose tested in the study
Authors
Doris Quon, Yu-Min Shen, Michael Tarantino, Nadia Ewing, Lisa Boggio, Miguel Escobar, Margaret Ragni, Amy Shapiro, Jonathan Ducore
Related Therapeutic Areas
Sponsors
Leads: OPKO Health, Inc.