The first-in-human study with ACT017 will be conducted at QPS facilities in Groningen, the Netherlands.
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 enroll 48 patients 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 2,000mg.
The goal is to assess safety and tolerance as well as parameters of hemostasis and coagulation and to determine pharmacokinetic and pharmacodynamic 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: https://www.qps.com
Chief Executive Officer
Tel: +33(0) 1 44 71 00 12 / +33(0) 6 88 20 35 59
Vice President Early Phase Clinical