A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous administration of a long-acting recombinant factor VIIa (MOD-5014) in healthy adult males.
This will be a single-dose, randomized, single-blind, placebo-controlled, dose-escalating study. The study will include four escalating dose groups, with eight subjects in each dose group. Subjects will be randomized in 3:1 ratio to receive a single SC injection of MOD-5014 (n=6) or a placebo (n=2), and will be followed up for 30 days. The initial MOD-5014 dose group will receive 100 µg/kg followed by single doses of 200, 400 and 600 µg/kg administered to subsequent subject cohorts. The decision to proceed to the higher dose level will be made by a Data Safety Monitoring Board (DSMB) after review of relevant safety data (including adverse events, clinical laboratory and vital signs), collected up to and including 7 days after the last subject of the previous dose group has been dosed. Common Terminology Criteria for Adverse Events (CTCAE) guidelines will be used to determine maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Dose escalation will be permitted if the prior dose is well tolerated, and there are no safety or tolerability concerns raised by the investigator, sponsor, medical monitor or DSMB over 7 days post-dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
32
MOD-5014, a long-acting modified recombinant Factor VIIa
Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes
TASMC
Tel Aviv, Israel
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), Immunogenicity, laboratory results, vital signs and injection site reactions
Time frame: within 30 days of injection
Cmax of MOD-5014
Time frame: within 30 days of injection
Tmax of MOD-5014
Time frame: within 30 days of injection
AUC(0-t) of MOD-5014
Time frame: within 30 days of injection
AUC(inf) of MOD-5014
Time frame: within 30 days of injection
T(½) of MOD-5014
Time frame: within 30 days of injection
Clearance of MOD-5014
Time frame: within 30 days of injection
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