PARIS--(BUSINESS WIRE)--Acticor Biotech, a biotechnology company focused on the treatment of acute ischemic stroke, today announced that it selected its CRO (Contract Research Organization) to manage its clinical study phase I.
The first-in-human study with ACT017 will be conducted at QPS facilities in Groningen, the Netherlands. QPS is a GLP/GCP-compliant contract research organization supporting discovery, preclinical and clinical drug development.
The submission is planned for September 2017 and the first cohort of volunteers is planned for October 2017. The clinical study will enrol 48 subjects in 6 escalating dose level cohorts, with each cohort consisting of 8 subjects: 6 on active and 2 on placebo at the following planned doses: 100, 250, 500, 750, 1,000 and 2,000 mg.
The goal is to assess safety and tolerance as well as parameters of haemostasis and coagulation and to determine pharmacokinetic and pharmacodynamics parameters.
About Ischemic stroke: http://acticor-biotech.com/en/stroke/
About ACT017, the Therapeutic Candidate: http://acticor-biotech.com/en/technology/
About Acticor Biotech: https://acticor-biotech.com/
About QPS Holdings, LLC: http://www.qps.com