French biotechnology firm Acticor Biotech has entered an agreement to study Dutch Authorities' investigational drug candidate ACT017 in a Phase I clinical trial with healthy subjects.
ACT017 is a humanised fragment of monoclonal antibody (Fab) being developed to target a platelet glycoprotein (GPVI) associated with thrombosis.
To be conducted at the QPS clinical research centre in the Netherlands, the randomised, double-blind, placebo-controlled single escalating dose Phase I trial will begin enrolment by the end of this month.
The trial will involve a total of 48 volunteers in six escalating dose cohorts for the evaluation of 62.5, 125, 250, 500, 1,000 and 2,000mg doses of ACT017.
With safety and tolerance as the primary endpoint, the trial will monitor pharmacokinetic, pharmacodynamic, haemostasis, and coagulation parameters, along with bleeding time.
Results from the Phase I trial are expected to be reported in the first quarter of next year and are intended to establish a suitable ACT017 dosage for Phase II clinical trials.
Being developed for the treatment of ischemic stroke, ACT017 is reported to have demonstrated favourable outcome in preclinical studies with primates, when compared to an approved fibrinolytic drug called rtPA (Actilyse).
According to the data, ACT017 did not show any interference when given in combination with rtPA, compared to monotherapy of ACT017 or rtPA.
The firm also reported that no additional intracerebral bleeding was observed in stroke animal model administered with ACT017 after three hours of cerebral thrombosis induction.