PK, PD, Tolerability and Safety of MDPK67b in Healthy Volunteers

Summary

This is a Phase I, single centre, prospective, randomized, alternating panels, ascending doses with interspersed placebo, double-blind, crossover trial. The trial will include 8 volunteers divided into 2 panels (A and B) investigated in alternance, each submitted to 4 investigation periods following a crossover design in double blind, with ascending intravenous doses of MDPK67b and an interspersed placebo. The ascending dose sequence ranges from 2 to 48 mg, with 2-fold increase steps (3 to 4- fold increase steps in each individual volunteer). Three single doses will be administered at a minimum of 2 weeks intervals during the first 3 periods, and finally during the last period 4 repeated doses will be administered at a three days intervals, using either the highest dose of the ascending sequence (i.e. 24 or 48 mg) or the maximal tolerated dose (if it has been exceeded in the ascending sequence of single doses).

Timeline

Start

2017-02-21

Primary completion

2017-06-07

Completion

2017-06-07

Drugs

Indications