A Phase 1 interventional study of MOD-5014 in Hemophilia A and Hemophilia B, sponsored by OPKO Health, Inc.. Completed at 11 sites in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by OPKO Health, Inc. · Phase 1, Interventional, and Treatment
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 27 is close to the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →OPKO Health, Inc. is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lowest MOD-5014 dose tested in the study
Drug: MOD-5014
MOD-5014 Dose cohort 2
Drug: MOD-5014
MOD-5014 Dose cohort 3
Drug: MOD-5014
MOD-5014 Dose cohort 4
Drug: MOD-5014
MOD-5014 Dose cohort 5
Drug: MOD-5014
Highest MOD-5014 dose tested in the study
Drug: MOD-5014
Long Acting Factor VIIa
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
To assess the acute safety and tolerability of single intravenous (IV) administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.
Time frame: 30 days
Pharmacokinetic Profile
To evaluate the pharmacokinetic profile (MOD-5014 serum levels; Area Under the Curve (AUC); Cmax; Tmax; T1/2) of single IV administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.
Time frame: 14 days
Pharmacodynamic Profile (evaluate the pharmacodynamic response (FVIIa clotting activity, coagulation parameters) of single IV administration of escalating MOD-5014 doses)
To evaluate the pharmacodynamic response (FVIIa clotting activity, coagulation parameters) of single IV administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.
Time frame: 14 days
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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OPKO Health, Inc.