QPS tapped for Acticor Biotech FIH study

By Melissa Fassbender contact

- Last updated on GMT

QPS tapped for Acticor Biotech FIH study

Related tags: Contract research organization

Acticor Biotech has contracted QPS to manage a Phase I study of the company’s humanized Antibody Fragment, ACT017.

Acticor is developing ACT017, a humanized Antibody Fragment (Fab) directed against platelet glycoprotein VI (GPVI).

According to the company, the antithrombotic efficacy of ACT017 and safety of inhibition of GPVI have been established ex vivo and in vivo.

QPS will conduct the first-in-human study​ at its facilities in Groningen, the Netherlands with the goal of assessing safety and tolerance in addition to parameters of haemostasis and coagulation.

The contract research organization (CRO) will also determine pharmacokinetic and pharmacodynamics parameters.

Submission is planned for September 2017 and the first volunteer cohort is planned for October 2017.

The clinical study will enroll 48 subjects in six escalating dose level cohorts, with each cohort consisting of 8 subjects.

(Feature image: iStock/shironosov)

Related topics: Clinical Development, Phase I-II

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